Daily4h
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 ...
Pharmabiz7h
US FDA accepts for review GSK’s BLA for depemokimab for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
US FDA accepts for review GSK’s BLA for depemokimab for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps: London, UK Tuesday, March 4, 2025, 09:0 ...
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 ...
Pharm Exec15h
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 Pharma18h
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.
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 ...
FiercePharma19h
Sinusitis data from Amgen, AZ's Tezspire spark 'best-in-disease' talk amid Sanofi, GSK competition
Already billed as a potential blockbuster, Amgen and AstraZeneca’s Tezspire has turned in strong clinical data in chronic ...
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 ...
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.
EconoTimes1d
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 ...
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 ...
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 ...