FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.
UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...
FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide c...
CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agency ahead of the new i...
Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degeneration drug Lucentis.
