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Merck KGaA, a leading science and technology company, announced a strategic collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui)

LianBio a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, announced topline results from the Phase III LIBRA clinical trial evaluating TP 03 in Chinese patients with Demodex blepharitis

Galapagos NV and Alfasigma S.p.A. announced that they have signed a letter of intent contemplating a transfer of the Jyseleca business to Alfasigma, including the European and UK Marketing Authorizations, the commercial, medical and development activities for Jyseleca and approximately 400 positions in 14 European countries

Sarepta Therapeutics, Inc. announced topline results from EMBARK (Study SRP-9001-301), a global, randomized, double-blind, placebo-controlled, Phase III clinical study of Elevidys (delandistrogene moxeparvovec-rokl) in patients with Duchenne muscular dystrophy between the ages of 4 through 7 years

Reviva Pharmaceuticals Holdings, Inc. announced positive topline results and successful completion of its pivotal Phase III RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia

the janssen pharmaceutical companies of johnson & johnson have announced results from the phase iii mariposa-2 study

Novartis announced positive topline results from the interim analysis of the ongoing pivotal Phase III ALIGN study (NCT04573478) of atrasentan, an oral endothelin A receptor antagonist (ERA), in patients with IgA nephropathy (IgAN)

Edwards Lifesciences Corporation announced one-year results from CLASP IID, the first randomized controlled trial that directly compares two contemporary mitral transcatheter edge-to-edge repair (TEER) therapies, as well as one-year results from the CLASP IID registry.

Bristol Myers Squibb said on October 25 that it has filed a new drug application for its ROS1 inhibitor repotrectinib for the treatment of ROS1-positive non-small cell lung cancer (NSCLC) in Japan.

ImmunoGen, Inc. announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (Elahere) for the treatment of patients with folate receptor alpha (FR alpha)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the FDA approved Loqtorzi (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced recurrent or metastatic Nasopharyngeal Carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

munityBio, Inc. a clinical-stage immunotherapy company, announced that the FDA has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N 803 (Anktiva), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.

Santhera Pharmaceuticals announces that the FDA has approved Agamree (vamorolone) oral suspension 40 mg/ml for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new data for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous (IV) use, in the Late Breaking Symposium 4 "Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration" at the 16th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference held in Boston, Massachusetts, United States and virtually October 24-27, 2023

-MaaT Pharma announced that the DSMB unanimously recommended that the open-label, single arm pivotal Phase III clinical trial evaluating MaaT 013 in acute Graft-versus-Host Disease (aGvHD), named ARES, continues without modification

Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults

On October 24, 2023, the FDA approved ivosidenib (Tibsovo), from, Servier Pharmaceuticals LLC for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test

Pfizer Inc. announced that the FDA has approved Penbraya ( that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age

For the first time, a panel of spinal cord stimulation (SCS) experts has developed best practices in the nascent field of remote SCS device management

Edwards Lifesciences announced new data from the PARTNER 3 trial demonstrating continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years

Amgen announced data from the global Phase III CodeBreaK 300 trial evaluating two doses of Lumakras (sotorasib) (960 mg or 240 mg) in combination with Vectibix (panitumumab)

Merck Inc., (known as MSD outside of the United States and Canada) announced results from the Phase III KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating Keytruda, Merck’s anti-PD-1 therapy, plus Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, compared to chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)

Exelixis Inc. announced detailed results from CABINET, a phase III pivotal trial evaluating cabozantinib (Cabometyx) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET)

Medtronic plc announced four-year results from the Evolut Low Risk Trial

LianBio announced that the company has entered into an agreement with Bristol Myers Squibb (BMS), whereby BMS has obtained LianBio’s exclusive rights to develop and commercialize mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Singapore and Thailand, in conjunction with termination of the exclusive license agreement LianBio previously entered into with MyoKardia, Inc., now a wholly owned subsidiary of BMS, in August 2020 to acquire such rights

Data from the REAL-PE study was presented at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, demonstrating that patients treated for pulmonary embolism (PE) with the Boston Scientific EKOS Endovascular System (EKOS) had lower rates of adverse events, including statistically significant lower rates of major bleeding, within seven days following their procedure compared to the Inari FlowTriever System

ImmunityBio, Inc. a clinical-stage immunotherapy company, announced it has completed the resubmission of its Biologics License Application (BLA) to the FDA for N 803 (Anktiva), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease

Abbott announced data from late-breaking presentations showing the impact of its minimally invasive heart devices in treating mitral and tricuspid valve disease

CEL-SCI Corporation announced that it has finalized the selection criteria for the head and neck cancer target population to be treated with the Company’s immunotherapy drug Multikine (Leukocyte Interleukin, Injection)

Potential to be the first and only self-administered flu vaccine; AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the FDA

Moderna, Inc. announced that the first participant has been dosed in a Phase III study of the Company's combination vaccine candidate against influenza and COVID-19 (mRNA-1083) in the U.S

KalVista Pharmaceuticals, Inc. announced the presentation of a novel analysis characterizing hereditary angioedema (HAE) attacks occurring in patients receiving long-term prophylaxis (LTP) treatments at the Asia Pacific Association of Allergy, Asthma and Clinical Immunology 2023 International Conference (APAAACI) in Singapore

Novartis has completed its transformation into a “pure-play” innovative medicines business, with the successful spin-off of Sandoz. Our focus is now centered on four core therapeutic areas (cardiovascular, renal and metabolic; immunology; neuroscience, and oncology)

Novartis presented late-breaking results from a prespecified exploratory subgroup analysis of invasive disease-free survival (iDFS) from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2023

Novartis presents data from the Phase III PSMAfore trial at the 2023 European Society for Medical Oncology (ESMO) Congress Data presented at the Presidential Symposium showed that Pluvicto (lutetium (177Lu) vipivotide tetraxetan) met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI

Positive results from the pivotal TROPION-Lung01 Phase III trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy

Sumitomo Pharma Canada, Inc. and Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for Myfembree (Relugolix, estradiol and norethindrone acetate tablets) for the management of moderate to severe pain associated with endometriosis in pre-menopausal women on October 17, 2023

Roche announced the entry into a definitive agreement to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc..

AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy

Patients with moderate-to-severe atopic dermatitis who continued treatment with investigational lebrikizumab for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing as demonstrated in the ADjoin long-term extension study from Eli Lilly and Company

Takeda announced that the European Commission (EC) approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Updated results from the BEGONIA Phase Ib/II trial for the cohort of patients treated with datopotamab deruxtecan (Dato-DXd) plus Imfinzi (durvalumab) (Arm 7) showed that the combination demonstrated durable tumour responses and no new safety signals in patients with previously untreated advanced or metastatic triple-negative breast cancer (TNBC) with six months additional follow-up from the previous data cut-off.

Merck Inc. known as MSD outside of the United States and Canada, announced results from the Phase III LITESPARK-005 trial investigating Welireg, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies

Regeneron Pharmaceuticals, Inc. announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC).

Eli Lilly and Company announced five-year outcomes from a pre-planned analysis of the Phase III monarchE study evaluating two years of adjuvant Verzenio (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology (ESMO) Congress.

Eli Lilly and Company announced results from both the LIBRETTO-431 Phase III study, which evaluated Retevmo (selpercatinib) versus platinum-based chemotherapy — with or without pembrolizumab — as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the LIBRETTO-531 Phase III study, which evaluated Retevmo versus multikinase inhibitors (MKIs) in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC).

Positive results from the primary analysis of the DUO-E Phase III trial showed that Imfinzi (durvalumab) plus platinum-based chemotherapy, followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib), both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone in the overall trial population of patients with newly diagnosed advanced or recurrent endometrial cancer.

Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, announced that the FDA has approved the New Drug Application for Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older.

Results from a prespecified exploratory analysis of the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of chemotherapy demonstrated a 42% improvement in central nervous system (CNS) progression-free survival (PFS), compared to Tagrisso alone for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) and brain metastases at baseline, representing 40% of patients in the trial, as assessed by blinded independent central review (BICR).

BioMarin Pharmaceutical Inc. announced that the FDA has approved the supplemental New Drug Application (sNDA) for Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates).

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU)

Merck Inc., known as MSD outside of the United States and Canada, announced results from the pivotal Phase III KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating Keytruda Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) for newly diagnosed patients with high-risk locally advanced cervical cancer (stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease).

Takeda announced that the Phase III ADMIRE-CD II study, assessing the efficacy and safety of Alofisel (darvadstrocel) for the treatment of complex Crohn’s Perianal Fistulas (CPF), did not meet its primary endpoint of combined remission at 24 weeks, based on topline data. The safety profile for darvadstrocel was consistent with prior studies and there were no new safety signals identified.

Daiichi Sankyo and Merck Inc., (known as MSD outside of the United States and Canada) have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd).

Bristol Myers Squibb announced that the Phase III CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint.

Edwards Lifesciences Corporation announced the company's EVOQUE tricuspid valve replacement system received CE Mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR) . The EVOQUE system is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR.

Intellia Therapeutics, Inc. announced that the FDA has cleared the company’s Investigational New Drug (IND) application for NTLA 2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy .

Ardelyx, Inc. announced that the FDA has approved Xphozah (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

New data from Tzields’s (teplizumab-mzwv) PROTECT Phase III trial were presented at the 49th Annual ISPAD Conference, in Rotterdam, The Netherlands.

Novavax, Inc. announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.

Soliris (eculizumab) from Alexion Pharma/AstraZeneca has been approved in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+) .

BeiGene, Ltd. announced results from the final analysis of the Phase III RATIONALE 305 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) in the intent-to-treat (ITT) population as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

UCB, a global biopharmaceutical company, announced that Zilbrysq (zilucoplan) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.

BeiGene, Ltd. announced that the Phase III RATIONALE 315 study met its dual primary endpoints of major pathological response (MPR) by Blinded Independent Pathology Review (BIPR) and event-free survival (EFS) by Blinded Independent Central Review (BICR), demonstrating statistically significant and clinically meaningful improvements in patients with resectable Stage II or IIIA NSCLC treated with tislelizumab in combination with chemotherapy before surgery and as a single agent after surgery versus neoadjuvant chemotherapy plus placebo followed by placebo after surgery.

UCB, a global biopharmaceutical company, announced that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Roche announced that the Elecsys IL-6 immunoassay has become the first IL-6 test to have a certified claim for use in diagnosis of neonatal sepsis, in countries accepting the CE Mark. Elecsys IL-6 aids physicians in combating the impact of neonatal sepsis by facilitating an early diagnosis.

Genentech, a member of the Roche Group announced results from the primary analysis of the Phase III ALINA study demonstrating a statistically significant and clinically meaningful improvement in disease-free survival (DFS; primary endpoint)

Novartis,, announced that the FDA has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

Merck Inc., known as MSD outside of the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]).

Sobi and Apellis Pharmaceuticals, Inc. announced that positive results from the Phase II NOBLE study investigating pegcetacoplan for the treatment of post-transplant recurrence of primary immune complex membrano-proliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G) will be presented at the American Society of Nephrology (ASN) Kidney Week Annual Meeting.

Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable (tumors greater than 4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

Hansa Biopharma announced results from an extended pooled analysis using data from the 17-HMedIdeS-14 study, an international long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase, showing sustained positive outcomes out to 5 years in the majority of highly sensitized patients who received an imlifidase-enabled kidney transplant.

Medac Gesellschaft für klinische Spezialpräparate mbH withdrew its application for a marketing authorisation of Jivadco (trastuzumab duocarmazine) for the treatment of HER2-positive breast cancer.

Astellas Pharma Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to the use of Vezoa (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Immedica announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in patients two years and older.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the granting of a marketing authorisation for Elucirem (gadopiclenol)(Vueway in the US) in the European Union (EU) for use in adults and children aged 2 years and over for MRI with contrast enhancement.

The Committee for Medicinal Products for Human Use (CHMP) adopted on 12 October 2023, a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Elrexfio, intended for the treatment of multiple myeloma. The applicant for this medicinal product is Pfizer Europe MA EEIG.

Arcutis Biotherapeutics Inc. announced new data from its pivotal ARRECTOR Phase III trial of roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis.

Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has received 510(k) clearance from the FDA for its TriLEAP Lower Extremity Anatomic Plating System, a comprehensive yet modular, procedure-specific system designed to meet the complex needs of orthopaedic surgeons, doctors of podiatric medicine, and foot and ankle specialists.

AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

Detailed results from Eli Lilly and Company's phase III SURMOUNT-3 clinical trial evaluating tirzepatide in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in Nature Medicine and simultaneously presented at ObesityWeek® 2023.

An open-label, international study published in the New England Journal of Medicine found that patients receiving Spravato (esketamine) CIII nasal spray for treatment-resistant depression (TRD) were 1.54 times as likely to reach remission after eight weeks than those treated with quetiapine extended-release (XR) at Week 8, (27.1% vs. 17.6%, respectively).

Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc announced interim data from the Phase II portion of the Phase II/III Orbit study demonstrating that treatment with setrusumab (UX 143) significantly reduced incidence of fractures in patients with OI with at least 6 months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density (BMD)

Pfizer Inc. announced that the FDA has approved Braftovi(encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

Pfizer Inc. announced that the FDA has approved Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). The approved recommended dose for Velsipity is 2 mg.

Almirall S.A., announced the presentation of new data on lebrikizumab through 18 abstracts, including two oral presentations at the European Academy of Dermatology and Venereology (EADV) Congress held in Berlin from October 11th to 14th.

Bristol Myers Squibb announced that Opdivo(nivolumab) was approved by the FDA for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients. The approval is based on the Phase III CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 1).

Genentech, a member of the Roche Group announced new data from the Phase II FENopta study showing that investigational, oral fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis (RMS), with a consistent safety profile to other fenebrutinib trials .

BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of Brukinsa (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy .

Cidara Therapeutics, Inc. a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, and Mundipharma announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.

UCB, announced the first analyses of pooled data from the two Phase III bimekizumab studies (BE HEARD I and BE HEARD II) in moderate to severe hidradenitis suppurativa (HS).

Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, announced that 30 company-sponsored presentations will be featured at the European Academy of Dermatology and Venereology (EADV) Congress taking place in Berlin, Germany from October 11-14, 2023.

EpimAb Biotherapeutics, a clinical stage biopharmaceutical company specializing in the development of multispecific antibodies, and Almirall, a global biopharmaceutical company focused on medical dermatology, announced a license agreement on the development of bispecific antibodies for up to three undisclosed target pairs.

Promore Pharma AB announced that the company has started an orderly shutdown.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Type II extension of indication application to the European Medicines Agency (EMA) seeking approval of Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Santhera Pharmaceuticals announces that the CHMP adopted a positive opinion in favor of approval of Agamree(vamorolone) for the treatment of DMD patients aged 4 years and older.

Eli Lilly and Company announced that mirikizumab (an investigational interleukin-23p19 antagonist) met the co-primary and all major secondary endpoints compared to placebo in VIVID-1, a Phase III study evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease.

Bristol Myers Squibb announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.

Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT 04, a biosimilar candidate to Stelara (ustekinumab).

Roche announced new clinical and real-world data for Ocrevus (ocrelizumab), demonstrating its role in continuing to transform care for people living with relapsing or primary progressive multiple sclerosis (RMS or PPMS) presented at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).

Genentech, a member of the Roche Group announced late-breaking data from the Phase III OCARINA II study.

Almirall S.A. has unveiled new data at the European Association of Dermatology and Venereology Congress 2023 in posters showed that Ilumetri (tildrakizumab) significantly improved the wellbeing of psoriasis patients, as well as the wellbeing of their relatives.

Merck KGaA, a leading science and technology company, announced new five-year data from the open-label extension (OLE) of the Phase II clinical trial, which demonstrated that people with relapsing multiple sclerosis (RMS) treated with investigational BTK inhibitor (BTKi) evobrutinib continued to have low annualized relapse rates (ARR) , with a high proportion of patients showing no evidence of clinical worsening.

Hansa Biopharma announced randomization for the US ConfIdeS trial is expected to conclude in mid-2024. The ConfIdeS trial is an open-label, controlled, randomized Phase III trial evaluating 12-month kidney function in highly sensitized (cPRA greater than 99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. Hansa plans to submit a Biologics License Application (BLA) under the accelerated approval pathway to the FDA in 2025.

Genentech, a member of the Roche Group announced results from the Phase IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial evaluating Ocrevus (ocrelizumab) in Black and Hispanic / Latinx people with relapsing multiple sclerosis (MS)

Alexion, AstraZeneca Rare Disease, will present new data at MSMilan2023, the 9th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS), taking place 11 to 13 October 2023.

Novo Nordisk announced the decision to stop the kidney outcomes trial FLOW (Effect of semaglutide versus placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease).

AbbVie will share new data from its robust gastroenterology portfolio at the United European Gastroenterology (UEG) Week 2023 Congress taking place in Copenhagen, Denmark from October 14-17.

Xenon Pharmaceuticals Inc. announced the medical journal JAMA Neurology has published peer-reviewed efficacy and safety results from the X-TOLE Phase IIb randomized clinical trial of XEN 1101, a novel potassium channel opener, in adults with focal epilepsy.

Merck Inc., announced the Phase III KEYNOTE-671 trial investigating Keytruda, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS).

Merck KGaA, a leading science and technology company, announced the presentation of new analyses from the Mavenclad(cladribine tablets) MAGNIFY-MS study, which demonstrated that patients with relapsing multiple sclerosis (RMS) experienced sustained reduction in serum neurofilament light chain (NfL), indicating that Mavenclad reduced neuronal injury over two years.

Genentech, a member of the Roche Group announced positive topline long-term results from the global Phase III BALATON and COMINO studies evaluating extended treatment intervals with Vabysmo (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).

Alnylam Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) in response to the Company’s supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating Keytruda, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma versus observation.

Coherus BioSciences, Inc. announced the Company has resubmitted the Biologics License Application (BLA) Supplement for Udenyca Onbody, biosimilar, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), to the FDA for review.

Bristol Myers Squibb and Mirati Therapeutics, Inc. announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Mirati for $58.00 per share in cash, for a total equity value of $4.8 billion

Cytokinetics, Incorporated announced that the baseline characteristics of patients randomized in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase III clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the HCM Society Scientific Sessions in Cleveland, Ohio by Martin S. Maron, M.D., Director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center

In a 10-to-2 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted that the data for progression-free survival (PFS) per blinded independent central review (BICR) from the phase III CodeBreaK 200 trial (NCT04303780) evaluating sotorasib (Lumakras) vs docetaxel for the treatment of patients with pretreated, locally advanced or metastatic KRAS G12C–mutated non–small cell lung cancer (NSCLC) cannot be reliably interpreted

UCB, a global biopharmaceutical company, announced that it will present new data on bimekizumab at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, October 11–14th in Berlin, Germany

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new indication for Jemperli (dostarlimab), a treatment for some types of endometrial cancer in adults.

Following an extensive review of the pipeline, UniQure will discontinue more than half of its research and technology projects, including AMT-210 for the treatment of Parkinson’s disease and multiple undisclosed programs.

The FDA has approved Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) combination therapy for people with late-onset Pompe disease (LOPD) who weigh at least 40 kg and are not improving on current enzyme replacement therapy (ERT).

Alnylam Pharmaceuticals, Inc. announced that the Company will present new results for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis, at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2023 , October 6-9, 2023.

Arcutis Biotherapeutics, Inc. announced the FDA has approved the supplemental new drug application (sNDA) to expand the indication of Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years.

Kyowa Kirin acquires Orchard Therapeutics

AbbVie announced that it has exercised its exclusive right and completed the acquisition of Mitokinin, a discovery-stage biotechnology company developing a potentially first-in-class disease-modifying treatment for Parkinson's Disease (PD)

Innate Pharma announced that the FDA has placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase II TELLOMAK) and 102 (Phase 1b PTCL)

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced that the FDA has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation

Janssen Pharmaceuticals, Inc. a Johnson & Johnson Company, announced a development and commercialization agreement with Sanofi for Janssen’s extraintestinal pathogenic Escherichia coli (ExPEC) investigational vaccine program

Novartis will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) Congress 2023, highlighting latest developments from across its oncology portfolio and addressing unmet needs of patients diagnosed with some of the most prevalent cancers, including prostate and breast

Neurelis, Inc., announced additional findings from the post hoc analysis of the long-term phase III safety study of Valtoco (diazepam nasal spray) in a pediatric population, aged 6-17 years, as well as an analysis of real-world data on impact of administration of rescue medication on seizure timing

Eli Lilly and Company and POINT Biopharma Global, Inc. announced a definitive agreement for Lilly to acquire POINT, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer

Regeneron Pharmaceuticals, Inc. and Intellia Therapeutics, Inc. announced an expanded research collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases

SeaStar Medical Holding Corporation announces receipt of a correspondence from the FDA Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU)

Invitae Corporation, a leading medical genetics company, announced it gained FDA market authorization for its Common Hereditary Cancers Panel

Roche presented positive results from the primary analysis of the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi (risdiplam) in babies with pre-symptomatic SMA (n=26), aged from birth to six weeks

Novavax, Inc. a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the FDA for active immunization to prevent COVID-19 in individuals aged 12 and older

Syndax Pharmaceuticals announced positive topline data from the protocol-defined pooled analysis of the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL)

Takeda announced that, following discussions with the FDA, it will be working with the FDA towards a voluntary withdrawal of Exkivity (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy

Syros Pharmaceuticals, a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies announced a strategic realignment to prioritize key development and pre-launch activities to advance tamibarotene for the frontline treatment of higher-risk myelodysplastic syndrome (HR-MDS) and acute myeloid leukemia (AML)

The World Health Organization (WHO) announced its recommendation of the R21/Matrix-M malaria vaccine to prevent malaria in children following advice from its Strategic Advisory Group of Experts (SAGE) and Malaria Policy Advisory Group (MPAG)

Synaptogenix, Inc. announced a peer-reviewed publication of statistically significant integration of secondary and exploratory endpoint data from its previously completed Phase II trial of Bryostatin-1 for Alzheimer's disease

BeiGene, Ltd. announced that the European Commission (EC) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy

Eli Lilly and Company announced that the FDA has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema)

Novartis announced positive top-line results from the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study (NCT04578834) at 9 months.

The phase III ENHANCE-2 trial (NCT04778397) examining the frontline combination of magrolimab and azacitidine (Vidaza) vs physician’s choice of venetoclax (Venclexta) with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome (Ph)–positive, chronic-phase chronic myelogenous leukemia (CP-CML) that is newly diagnosed or resistant or intolerant to prior therapy

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy

AbbVie announced data from its Phase III CANOVA study evaluating the safety and efficacy of venetoclax (Venclexta/ Venclyxto plus dexamethasone (VenDex) for patients with t(11;14)-positive relapsed or refractory (R/R) multiple myeloma who have received two or more prior treatments

Bayer will present the latest RWE research results which focuses on treatment utilization and pathways in women with menopausal symptoms at the upcoming Menopause Society Annual Meeting (formerly The North American Menopause Society)