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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

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

FDA Accepts Autolus Obe-Cel BLA

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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

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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

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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

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

Orthopedic Device Coatings Guidance

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FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical device...

OPDP Letter Cites Novartis on Kisqali Ad

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CDERs Office of Prescription Drug Promotion (OPDP) faults a Novartis direct-to-consumer TV ad promoting it breast cancer therapy K...

Ionis Plans NDA for Donidalorsen

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Ionis Pharmaceuticals plans an NDA submission based on data from the Phase 3 OASIS-HAE study in people with hereditary angioedema.