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FDA approves higher dose of Catalyst's LEMS drug By Investing.com
Investing.com· 2 days agoCatalyst Pharmaceuticals, Inc. (NASDAQ: CPRX), a commercial-stage biopharmaceutical company,...
FDA approves new tool to enhance cataract surgery outcomes
Medical Device Network via Yahoo Finance· 5 days agoThe US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology's...
FDA accepts Sanofi’s Sarclisa sBLA for priority review
Pharmaceutical Technology via Yahoo Finance· 4 days agoThe US Food and Drug Administration (FDA) has accepted for priority review Sanofi's supplemental...
FDA authorises CamDiab’s CamAPS FX artificial pancreas app
Medical Device Network via Yahoo Finance· 5 days agoThe US Food and Drug Administration (FDA) has granted authorisation for CamDiab’s adaptive hybrid...
FDA Approves Elanco's Methane-Reducing Cattle Feed Additive By Investing.com
Investing.com· 4 days agoElanco Animal Health Incorporated (NYSE:ELAN) has received approval from the U.S. Food and Drug...
FDA approves Terumo’s CDI OneView Monitoring System
Medical Device Network via Yahoo Finance· 3 days agoThe US Food and Drug Administration (FDA) has granted 510(k) clearance for Terumo Cardiovascular’s CDI OneView Monitoring System, which aims to enhance...
FDA finalizes guidance on “Remanufacturing” vs “Servicing” | JD Supra
JD Supra· 2 days agoIn June 2021, FDA issued draft guidance on “Remanufacturing of Medical Devices,” aiming to help clarify the point when manipulation or repair of a medical device becomes “ ...
FDA prioritizes review of Jazz Pharmaceuticals' new cancer therapy By Investing.com
Investing.com· 3 days agoJazz Pharmaceuticals (NASDAQ:JAZZ) announced that the U.S. Food and Drug Administration (FDA) has...
FDA fast tracks lung cancer treatment by Affimed By Investing.com
Investing.com· 3 days agoThe U.S. Food and Drug Administration (FDA) has granted Fast Track designation to a novel lung...
FDA says to return, toss Texas brand of baby formula
San Antonio Express-News· 4 days agoThe U.S. Food and Drug Administration (FDA) has recalled a Texas brand of baby formula over the weekend and is urging parents to return the formula for a...