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Elixir Med. Breakthrough Status for Bioadaptive Implant

[ Price : $8.95]

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

Syndax Leukemia Review Extended by FDA

[ Price : $8.95]

FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

Colon Cancer Blood Test Approved

[ Price : $8.95]

FDA approves Guardant Healths Shield blood test for colon cancer screening in adults 45 years of age and older who are at average ...

Brassica Pharma Hit with 10-item FDA-483

[ Price : $8.95]

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

[ Price : $8.95]

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...