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FDA advisers weigh benefits of weekly insulin for people with diabetes
KSBW Salinas· 21 hours agoFood and Drug Administration, but a committee of agency advisers is divided on whether the benefits...
Biden’s got a plan to protect science from Trump
Politico via Yahoo News· 2 hours agoTrump officials pressured the CDC to change language in a report about pediatric Covid cases in 2020. In the lead up to the 2020 election, Trump advisers mounted a pressure campaign on the & ...
FDA Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 5 days agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 3 days agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...
FDA panel gives nod to blood test for colon cancer
Medical Xpress· 22 hours agoThe panel voted 7-2 that the benefits outweighed the risks when using the Guardant Health's Shield test for colon cancer. "The advisory committee's strong support for the approval of Shield ...
US FDA staff flags risk of low blood sugar for Novo Nordisk’s weekly insulin
KFGO· 5 days ago(Reuters) - The U.S. Food and Drug Administration's (FDA) staff on Wednesday pointed to "notable...
What to know about the blood test to detect colon cancer recommended by an FDA panel
ABC News via Yahoo News· 3 days agoA blood test to screen for colorectal cancer is one step closer to receiving approval from the U.S....
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 6 days agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell...
BioresearchOnline· 4 days agoIn April 2024, the U.S. FDA released the draft guidance for industry Considerations for the Use of...
FDA panel backs Guardant’s blood test for colon cancer
MedTech Dive via Yahoo Finance· 3 days agoWilliam Blair analyst Andrew Brackmann said the FDA appears on its way to approving Shield. Still,...
