FierceBiotech2d
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 ...
Hosted on MSN2d
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.
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 ...
Pharm Exec1d
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, ...
Contract Pharma2d
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.
EconoTimes2d
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 ...
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 ...
Twice-yearly drug eases symptoms in chronic rhinosinusitis with polyps
An international collaboration of researchers, sponsored by GSK and working on behalf of the ANCHOR-1 and ANCHOR-2 trial ...
Daily1d
USFDA accepts GSK depemokimab applications for review for asthma, chronic rhinosinusitis
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License ...
GSK's Once-Daily Inhalers For Smoker's Lung Has Potential Benefits: Independent Organization Report
The Institute for Clinical and Economic Review (ICER) released a report on Monday assessing the clinical effectiveness and ...
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 ...