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CGMP Violations in Health Specialty Inspection

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

55 Novel Drugs Approved in 2023: Report

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

Juno Therapeutics Breyanzi Approved for Lymphoma

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

Rep Green Bill on Vaccine Data Transparency

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

FDA Marks Office of Womens Health 30th Anniversary

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FDA commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office o...

Eisai Starts Rolling BLA for Leqembi Autoinjector

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

Change Pediatric Acetaminophen Directions: Petition

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

Atraverses Hotwire Radiofrequency Guidewire Cleared

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FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart ac...

Abbott Recalls HeartMate 3 Pump Over Leaks

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Abbott recalls (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood or air leakages.

Complete Response Letter for 4-Dose Heplisav-B

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FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.