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Federal Register

Acosta Debarred over Counterfeit Cough Syrup Scheme

Federal Register notice: FDA issues an order permanently debarring Gina Acosta from providing services in any capacity to a person that has an approve...

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Federal Register

Technical Amendment on Animal Drug Regs

Federal Register notice: FDA posts a technical amendment to its animal drug regulations for labeling new animal drugs included on the agencys Index of...

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Medical Devices

FDA OKs Roche HPV Self-Collection Solution

FDA approves the Roche HPV self-collection solution that the company says can expand access and screening options to help eliminate cervical cancer.

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Human Drugs

CGMP Violations in Health Specialty Inspection

FDA warns Omaha, NE-based Cohere Beauty about CGMP violations in its Health Specialty drug manufacturing facility in Santa Fe Springs, CA.

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Human Drugs

55 Novel Drugs Approved in 2023: Report

The CDER Drug Trials Snapshop Summary Report 2023 provides statistics on the 55 novel drugs the Center approved in 2023.

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Biologics

Juno Therapeutics Breyanzi Approved for Lymphoma

FDA grants Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for adults with relapsed o...

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Biologics

Rep Green Bill on Vaccine Data Transparency

Rep. Mark Green (R-TN) introduces the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from fraudulent vaccine tr...

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FDA General

FDA Marks Office of Womens Health 30th Anniversary

FDA commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office of Womens Health in i...

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Human Drugs

Eisai Starts Rolling BLA for Leqembi Autoinjector

Eisai opens a rolling BLA submission for an autoinjector to deliver maintenance doses of Leqembi in patients with early Alzheimers disease.

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Human Drugs

Change Pediatric Acetaminophen Directions: Petition

Parenteral Technologies asks FDA to ban specific language from the directions for some liquid acetaminophen products indicated for certain infants.