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Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
Zacks via Yahoo Finance· 2 hours agoThe FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for...
Cheese recall update as FDA issues highest level of concern
Newsweek· 6 hours agoThe U.S. Food and Drug Administration (FDA) recently warned consumers that a brand of cheese...
FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)
The National Law Review· 2 hours agoFood and Drug Administration FDA establishes Center for Drug Evaluation and Research CDER Center for...
FDA warns that nicotine-like chemicals in vapes may be more potent than nicotine
Fox News· 2 hours agoNicotine alternatives like 6-methyl nicotine in vapes may be more addictive than nicotine, according...
Ro launches GLP-1 tracker amid ongoing shortage
Crain's New York Business· 4 hours agoRo said its tracker may be an alternative to relying on the FDA's drug shortage list, as that list only includes drugs by active ingredient and not brand name. The
Agios (AGIO) Up 23% on Selling Brain Cancer Drug Royalty
Zacks via Yahoo Finance· 1 hour agoAgios Pharmaceuticals (AGIO) agrees to sell to Royalty Pharma the rights to royalties on potential...
Inspira Technologies' (IINN) ART100 Gets FDA 510(k) Grant
Zacks via Yahoo Finance· 2 hours agoInspira Technologies OXY B.H.N. Ltd. IINN recently received the FDA 510(k) clearance for its INSPIRA...
FDA’s Final Rule on IVDs: a stop gap en route to the VALID Act?
Medical Device Network via Yahoo Finance· 8 hours agoAfter years of back and forth with industry, the FDA has made explicit that IVDs are medical devices...
Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca's Drug - Amgen...
Benzinga· 54 minutes agoTuesday, the FDA approved Amgen Inc AMGN Bkemv (eculizumab-aeeb) as the first interchangeable...
Nationwide spice recall update as FDA issues concern level
Newsweek· 1 day agoSeveral brands, produced by various manufacturers, were caught up in the recall published by the...