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FDA panel backs Guardant’s blood test for colon cancer
MedTech Dive via Yahoo Finance· 1 day agoWilliam Blair analyst Andrew Brackmann said the FDA appears on its way to approving Shield. Still,...
FDA advisory committee says risks of Novo Nordisk’s once-weekly insulin outweigh benefits in type 1...
Endpoints News· 15 hours agoAn FDA advisory committee on Friday voted not to recommend Novo Nordisk’s once-weekly insulin...
Novavax awaits FDA decision on whether its next COVID shot can be offered in US
Reuters via Yahoo News· 16 hours agoNovavax will only be able to offer a COVID-19 vaccine in the United States this autumn if regulators...
FDA monitoring plastic syringe supply chain
Politico· 20 hours agoThe recalls come amid an uptick in product import alerts from the FDA and after the agency’s latest warning to consumers and health care providers not to use the foreign-made ...
FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 1 day agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...
FDA Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 3 days agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
Exact Sciences stock drops as Guardant Health test supported by FDA panel By Investing.com
Investing.com· 22 hours agoFood and Drug Administration's (FDA) Medical Devices Advisory Committee has strongly recommended FDA...
US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
Reuters· 15 hours agoNovo is aiming to be the first to hit the market with a weekly insulin product, offering an...
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
BioPharma Dive via Yahoo Finance· 1 day agoBut the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening...
FDA advisory committee reviews Novo Nordisk insulin icodec for T1D
Pharmaceutical Technology via Yahoo Finance· 24 hours agoThe US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee is...