GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review
FDA reviews GSK depemokimab for asthma and CRSwNP, with a decision expected by December 2025. Phase 3 data shows improvements ...
Hosted on MSN2h
GSK reports positive outcomes from two Phase III trials of treatment for CRSwNP
Secondary endpoint analyses from the trials showed 'significant improvements' in patients treated with the antibody.
Pharm Exec1h
FDA Accepts Biologics License Application for GSK’s Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, ...
FierceBiotech15h
GSK gears up for depemokimab debut with twin FDA filings and phase 3 data dump
With Sunday’s Academy Awards ceremony in the rearview mirror, GSK is looking ahead to a potential blockbuster premiere of its ...
Contract Pharma4h
FDA Accepts GSK’s Depemokimab for Review
The US Food and Drug Administration (FDA) has accepted for review GSK’s Biologics License Application for depemokimab.
FDA Accepts Depemokimab Applications For Asthma With Type 2 Inflammation And CRSwNP
GSK plc (GSK) has announced on Monday that the FDA has accepted its Biologics License Application (BLA) for depemokimab for regulatory review in two indications.The proposed ...
GSK announces U.S. FDA accepted for review BLA for depemokimab
GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review the Biologics License Application, BLA, for the use of ...
EconoTimes11h
FDA Reviews GSK’s Depemokimab for Asthma and CRSwNP Treatment
The U.S. Food and Drug Administration (FDA) has accepted GlaxoSmithKlines (NYSE:GSK) biologics license application for ...
Hosted on MSN15h
Twice-Yearly Biologic Effective Against Nasal Polyps
Novel ultra-long-acting biologic depemokimab reduced nasal polyps in chronic rhinosinusitis, two parallel phase III trials ...
GSK says US FDA accepts two depemokimab indication submissions
(Alliance News) - GSK PLC on Monday said the US Food & Drug Administration has accepted for review the biologics license application for depemokimab in two indications - for asthma with type 2 ...
FDA to review GSK's depemokimab
Pharmaceutical giant GSK said on Monday that the US Food and Drug Administration has agreed to review its Biologics License ...
Investing15h
US FDA accepts GSK’s application for Depemokimab review
Investing.com -- The US Food and Drug Administration has accepted GlaxoSmithKline (NYSE: GSK )’s biologics license ...