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GSK (GSK) FDA Events

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FDA Events for GSK (GSK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by GSK (GSK). Over the past two years, GSK has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Benlysta, JEMPERLI, and Nucala. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

GSK's Drugs in FDA Review

Benlysta (Belimumab) - FDA Regulatory Timeline and Events

Benlysta (Belimumab) is a drug developed by GSK for the following indication: Lupus Nephritis (LN). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

JEMPERLI (dostarlimab-gxly) - FDA Regulatory Timeline and Events

JEMPERLI (dostarlimab-gxly) is a drug developed by GSK for the following indication: Recurrent or Advanced dMMR/MSI-H Endometrial Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Nucala (mepolizumab) - FDA Regulatory Timeline and Events

Nucala (mepolizumab) is a drug developed by GSK for the following indication: Adults with chronic rhinosinusitis with nasal polyps. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

GSK FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, GSK (GSK) has reported FDA regulatory activity for the following drugs: Nucala (mepolizumab), Benlysta (Belimumab) and JEMPERLI (dostarlimab-gxly).

The most recent FDA-related event for GSK occurred on June 24, 2025, involving Benlysta (Belimumab). The update was categorized as "FDA approved," with the company reporting: "GSK plc announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy."

Current therapies from GSK in review with the FDA target conditions such as:

  • Adults with chronic rhinosinusitis with nasal polyps - Nucala (mepolizumab)
  • Lupus Nephritis (LN) - Benlysta (Belimumab)
  • Recurrent or Advanced dMMR/MSI-H Endometrial Cancer - JEMPERLI (dostarlimab-gxly)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:GSK) was last updated on 7/10/2025 by MarketBeat.com Staff
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