FDA Related News

Human Drugs

FDA Fast Track for Kyverna MS Therapy

FDA grants fast track designation to an investigative Kyverna CAR-T drug to treat some patients with multiple sclerosis.

Human Drugs

CGMP Deviations Seen in Glicerinas Inspection

FDA warns Mexicos Glicerinas Industriales about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Human Drugs

FDA Accepts Autolus Obe-Cel BLA

Autolus Therapeutics says FDA has accepted for review its BLA for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cel...

Human Drugs

FDA Orders Safety Changes to 5 CAR-T Labels

FDA orders safety labeling changes for five CAR-T immunotherapies after investigating an identified risk of T-cell malignancy following their use.

Human Drugs

Court Allows 1 Vanda Claim Against FDA

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...

FDA, FTC Should Regulate Influencer Posts: Column

A StatNews column calls for FDA and FTC collaboration to regulate social media videos and comments from influencers on prescription drugs.

Medical Devices

Orthopedic Device Coatings Guidance

FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical devices.

Human Drugs

Pharvaris Clinical Hold Lifted

FDA lifts a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of hereditary angioedem...

Medical Devices

Draft Guide on Orthopedic Device Coatings

FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.

Biologics

Priority Review for Xolair Food Allergy sBLA

FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may ...