Pharm Exec4h
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, ...
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 ...
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...
JD Supra6d
Biologics and Biosimilars Landscape 2024: IP, Policy, and Market Developments
Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number ...
GlobalData on MSN3d
FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant ...
Merck’s application for keytruda in HNSCC granted priority review by FDA
Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – ...
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
ophthalmologytimes13d
Alvotech and Teva Pharmaceuticals announce FDA accepts Biologics License Application for AVT06
Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...
Nasdaq13d
Alvotech and Teva Pharmaceuticals Announce FDA Acceptance of Biologics License Application for AVT06 Biosimilar to Eylea®
Alvotech and Teva Pharmaceuticals announced that the U.S. FDA has accepted for review a Biologics License Application for AVT06, a proposed biosimilar to Eylea® (aflibercept), which treats eye ...
Nasdaq13d
Alvotech and Teva Pharmaceuticals Announce FDA Acceptance of Biologics License Application for AVT06, a Biosimilar Candidate to Eylea®
Alvotech and Teva Pharmaceuticals have announced the FDA's acceptance of their Biologics License Application for AVT06, a proposed biosimilar to Eylea®, aimed at treating various eye disorders ...