FDA warns Mexicos Glicerinas Industriales about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Autolus Therapeutics says FDA has accepted for review its BLA for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cel...
FDA orders safety labeling changes for five CAR-T immunotherapies after investigating an identified risk of T-cell malignancy following their use.
The U.S. Court of Federal Claims says one part of a Vanda claim against FDA involving the agencys actions in reviewing generic drug applications for t...
A StatNews column calls for FDA and FTC collaboration to regulate social media videos and comments from influencers on prescription drugs.
FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical devices.
FDA approves a Vanda Pharmaceuticals IND to evaluate VCA-894A for treating patients with Charcot-Marie-Tooth disease, axonal, Type 2S.
CDERs Office of Prescription Drug Promotion (OPDP) faults a Novartis direct-to-consumer TV ad promoting it breast cancer therapy Kisqali (ribociclib) ...
