Biotech News

PIVOT-PO phase III study for tebipenem HBr stopped early for efficacy following review by Independent Data Monitoring Committee

GSK plc (GSK)GSK plcFDA / regulatory

Data to be part of a planned US FDA filing in H2 2025

Related news

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 Medicines2026-07-22 20:05 EST

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

RVMDRevolution Medicines2026-07-07 13:24 EST

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

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)

INBXInhibrx2026-06-15 13:15 EST

Inhibrx Announces U.S. FDA Acceptance of BLA for Ozekibart in Patients with Conventional Chondrosarcoma

GSKGSK plc2026-07-28 11:00 EST

GSK’s licensor Hansoh Pharma announces positive results from a second phase III trial for Ris-Rez in China

GSKGSK plc2026-07-17 09:00 EST

GSK provides an update on CALM-1 and CALM-2 phase III trials for camlipixant in refractory chronic cough (RCC)

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

SRPTSarepta Therapeutics2026-06-30 12:30 EST

Sarepta Announces FDA Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®

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

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

Stock data

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