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Carie Boyd Pharma Hit with FDA-483

[ Price : $8.95]

FDA issues Carie Boyd Pharmaceuticals a six-observation Form FDA-483 after inspecting the firms Irving,TX outsourcing facility las...

Alpha Cognitions Zunveyl OKd for Alzheimers

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FDA approves an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimers disease.

Elixir Med. Breakthrough Status for Bioadaptive Implant

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FDA grants Elixir Medical a breakthrough device designation for its DynamX Sirolimus-Eluting Coronary Bioadaptor System for use in...

Brassica Pharma Hit with 10-item FDA-483

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A January inspection of Brassica Pharmas Indian sterile drug manufacturing facility leads to a 10-observation Form FDA-483 that ci...

Suns JAK Inhibitor OKd for Alopecia Areata

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FDA approves a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopec...

Pulmonary-Allergy Drugs Panel Renewal

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Federal Register notice: FDA announces the renewal for two years of its Pulmonary-Allergy Drugs Advisory Committee.

Pediatric Committee to Mull Safety of 41 Products

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Federal Register notice: FDA announces a 9/18 Pediatric Advisory Committee meeting that will discuss post-marketing pediatric-focu...

Alert on Compounded Semaglutide Overdoses

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FDA warns about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compou...

FDA Slaps Hold on Diabetes Investigational Drug

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FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX DE-ITALICIZE XXX)and its use i...

Blog Post on Device AI Lifecycle Model

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A new CDRH blog post outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled m...