Biotech News

Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)

GSK plc (GSK)GSK plc2026-03-19 12:00 ESTFDA / regulatory

Approval based on the positive GLISTEN phase III trial with regulatory reviews underway in the EU, UK, Canada and China

Related news

INBXInhibrx2026-06-15 13:15 EST

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

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

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)

GSKGSK plc2026-07-22 11:21 EST

Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-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

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

ENTAEnanta Pharmaceuticals2026-06-23 09:10 EST

Enanta Pharmaceuticals’ Partner AbbVie Receives European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus

GSKGSK plc2026-06-17 16:00 EST

Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

ELVNEnliven Therapeutics2026-06-11 12:00 EST

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

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

View all latest news

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 plc2026-07-29 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

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 plc2026-07-27 14:55 EST

ViiV Healthcare’s 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy in first-of-its-kind head-to-head study in treatment-naïve adults living with HIV

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