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Lawsuit Against FDA and Livestock/Poultry Antibiotic Use

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Several public health advocacy groups sue FDA, challenging its 2021 denial of a citizen petition that sought the withdrawal of med...

FDA Funding Opportunity for Pediatric Device Consortia

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FDA posts a new funding opportunity for its Pediatric Device Consortia grants program, which is open for applications through 3/29...

New Data Support Carvykti sNDA in Multiple Myeloma

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Janssen Pharmaceutical says it will submit an NDA supplement for Carvykti (ciltacabtagene autoleucel; cilta-cel) after announcing ...

Vanda Petitions FDA Over Teva Non-BrailleLabeling

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Vanda Pharmaceuticals petitions FDA to revoke the approval of a Teva ANDA for a generic copy of Vandas Hetlioz (tasimelteon) becau...

FDA Denies Petition on Jakafi Safety Labeling

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FDA denies a 3/2021 petition filed by Loeb & Loeb that asked the agency to take specific actions concerning the adequacy of safety...

Eschoo Reelected as Ranking Dem on Health Subcommittee

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Democrat members of the House Energy and Commerce Committee vote Rep. Anna G. Eshoo (D-CA) as ranking Democrat on the Health Subco...

LivaNova Again Recalls LifeSPARC Controller Over Software

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LivaNova (TandemLife) recalls its LifeSPARC Controller due to a problematic software update that was designed to address a previou...

FDA History Office Now Under Office of Operations

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Federal Register notice: FDAs Office of Operations (OO), Office of Enterprise Management Services (OEMS) modifies its organization...

Lilly Gets Accelerated Approval for Lymophoma Drug

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FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) for treating certain relapsed or refractory mantle cell lym...

Rep. Guthrie to Chair FDA Oversight Committee

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House leaders tap Representative Brett Guthrie (R-KY) to serve as chair of the House Energy and Commerce Committees Health Subcomm...