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Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review
Benzinga via Yahoo Finance· 14 hours agoThe FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on May 24 to...
FDA Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 19 hours agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
Recent FDA committee vote could speed multiple myeloma drug approval
Medical Xpress· 13 hours agoThe 12–0 vote by committee members was based primarily on an analysis spearheaded by C. Ola...
FDA classifies recall of Hologic's implant as 'most serious'
Reuters via Yahoo News· 15 hours agoThe FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a...
FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance | JD Supra
JD Supra· 1 day agoThe FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device ...
Amphastar Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol
Morningstar· 24 hours ago(NASDAQ:AMPH) today announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's Abbreviated New Drug Application ("ANDA") for Albuterol ...
FDA grants Cartesian Therapeutics RMAT status for MG therapy By Investing.com
Investing.com· 16 hours agoCartesian Therapeutics, a clinical-stage biotechnology company, announced today that the U.S. Food...
Roche’s Tina-quant Lp(a) test receives FDA breakthrough device designation
Medical Device Network via Yahoo Finance· 24 hours agoRoche has received the US Food and Drug Administration’s (FDA) breakthrough device designation for...
Larimar (LRMR) Up on Lifting of Partial Clinical Hold on FA Study
Zacks via Yahoo Finance· 18 hours agoLarimar Therapeutics, Inc. LRMR announced that the FDA has removed the partial clinical hold on its...
Dog food sold at Walmart recalled because it might contain 'loose metal pieces': FDA
NBC 10 Providence· 21 hours agoPedigree dog food recently sold at Walmart stores in four states was recalled "due to the potential...