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Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating A...[ Price : $8.95]
Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compo...[ Price : $8.95]
FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing...[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...[ Price : $8.95]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]
FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.[ 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...