FDA Related News

Human Drugs

Haleon Recalls 8 Robitussin Lots

Haleon recalls eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult due to microbial contamination concerns.

Medical Devices

Breakthrough Status for Colorectal Cancer Test

FDA grants Amadix a breakthrough device designation for PreveCol, a blood test for early detection of colorectal cancer.

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

Vanda Gets IND OK for Rare Disease

FDA approves a Vanda Pharmaceuticals IND to evaluate VCA-894A for treating patients with Charcot-Marie-Tooth disease, axonal, Type 2S.

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FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical devices.