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FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...[ Price : $8.95]
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...[ Price : $8.95]
CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agenc...[ Price : $8.95]
Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degenerati...[ Price : $8.95]
FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weigh...[ Price : $8.95]
Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labe...[ Price : $8.95]
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.[ Price : $8.95]
UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, af...