Biotech News

Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease (COPD)

GSK plc (GSK)GSK plcFDA / regulatory

Approval based on results from MATINEE showing significant reduction in the rate of moderate/severe exacerbations versus placebo

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Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

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Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

BMYBMYBristol-Myers Squibb Company2026-08-13 21:12 EST

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

IDYAIDEAYA Biosciences2026-08-31 10:00 EST

IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer

REPLReplimune Group2026-08-06 20:00 EST

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

COGTCogent Biosciences2026-09-15 12:00 EST

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

BNTXBioNTech2026-08-27 20:30 EST

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine

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U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer

GSK plc

Global Biopharmaceutical Portfolio GSK is a global biopharmaceutical company operating across Specialty Medicines, Vaccines, and General Medicines. Its commercial portfolio spans HIV, oncology, respiratory and immuno-inflammation, vaccines, and established medicines, supported by a growing late-stage pipeline and externally sourced...

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51.08 USD
Market cap
98.26B USD
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Vaccines, Biopharma, Gene Therapy, Antibody Drugs, Small Molecule Drugs, Nucleic Acid Drugs
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