FDA grants fast track designation to an investigative Kyverna CAR-T drug to treat some patients with multiple sclerosis.
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 approves a Vanda Pharmaceuticals IND to evaluate VCA-894A for treating patients with Charcot-Marie-Tooth disease, axonal, Type 2S.
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FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical devices.
