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GSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer

GSK plc (GSK)GSK plcFDA / regulatory

Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type

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GSKGSK plc2026-08-24 07:01 EST

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

BMYBMYBristol-Myers Squibb Company2026-07-13 10:59 EST

U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

GSKGSK plc2026-08-24 07:00 EST

Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B

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

RVMDRevolution Medicines2026-07-22 20:05 EST

Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer

TEVATeva Pharmaceutical Industries2026-08-19 12:30 EST

U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome

REGNRegeneron Pharmaceuticals2026-06-22 11:00 EST

Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)

REPLReplimune Group2026-07-30 22:15 EST

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

RVMDRevolution Medicines2026-07-07 13:24 EST

European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process

REPLReplimune Group2026-06-26 12:00 EST

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma

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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...

Recent company news

GSKGSK plc2026-08-24 07:01 EST

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

GSKGSK plc2026-08-24 07:00 EST

Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B

GSKGSK plc2026-07-29 09:08 EST

Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026

GSKGSK plc2026-07-28 12:05 EST

GSK to establish new flagship R&D centre on Cambridge Biomedical Campus, UK

GSKGSK plc2026-07-28 12:00 EST

GSK delivers strong Q2 core results performance and continued momentum. Plans announced to accelerate R&D and late-stage pipeline portfolio. Expect 20+ phase III trial starts in 2026

Stock data

Close
52.41 USD
Market cap
98.26B USD
Exchange
NYSE
Sector
Vaccines, Biopharma, Gene Therapy, Antibody Drugs, Small Molecule Drugs, Nucleic Acid Drugs
Location
United States