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Positive Gene Therapy Results for Some Hearing Loss

[ Price : $8.95]

A Lilly subsidiary says its investigational gene therapy for some genetic hearing loss showed positive results in a Phase 1/2 tria...

Haleon Recalls 8 Robitussin Lots

[ Price : $8.95]

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

Breakthrough Status for Colorectal Cancer Test

[ Price : $8.95]

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

FDA Fast Track for Kyverna MS Therapy

[ Price : $8.95]

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

CGMP Deviations Seen in Glicerinas Inspection

[ Price : $8.95]

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

FDA Accepts Autolus Obe-Cel BLA

[ Price : $8.95]

Autolus Therapeutics says FDA has accepted for review its BLA for obecabtagene autoleucel as a potential treatment for relapsed/re...

Vanda Gets IND OK for Rare Disease

[ Price : $8.95]

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

FDA Orders Safety Changes to 5 CAR-T Labels

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

Court Allows 1 Vanda Claim Against FDA

[ Price : $8.95]

The U.S. Court of Federal Claims says one part of a Vanda claim against FDA involving the agencys actions in reviewing generic dru...

FDA, FTC Should Regulate Influencer Posts: Column

[ Price : $8.95]

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