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4 Priority Review Vouchers Redeemed: FDA

[ Price : $8.95]

Federal Register notices: FDA posts four announcements about a priority review voucher being redeemed as part of a product approva...

CDRH Tech Innovation Group Now a Super Office

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CDRH says its Office of Strategic Partnerships and Technology Innovation has been elevated to a super office.

Positive Gene Therapy Results for Some Hearing Loss

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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

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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

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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

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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...