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GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA

GSK plc (GSK)GSK plcFDA / regulatory

Designation supported by early clinical data showing durable responses in certain types of small-cell lung cancer (SCLC)

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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

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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

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Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components

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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

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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