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Change Pediatric Acetaminophen Directions: Petition

[ Price : $8.95]

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

Atraverses Hotwire Radiofrequency Guidewire Cleared

[ Price : $8.95]

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

[ Price : $8.95]

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

Acosta Debarred over Counterfeit Cough Syrup Scheme

[ Price : $8.95]

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

Technical Amendment on Animal Drug Regs

[ Price : $8.95]

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

FDA OKs Roche HPV Self-Collection Solution

[ Price : $8.95]

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

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

[ Price : $8.95]

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

[ Price : $8.95]

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