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FDA advisers weigh benefits of weekly insulin for people with diabetes
CNN.com· 18 hours agoNow, the maker of a once-weekly insulin injection is seeking approval from the US Food and Drug...
FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request
Endpoints News· 5 days agoThe FDA on Friday withdrew an accelerated approval for Helsinn’s bile duct cancer drug, two years...
FDA upgrades safety alert for Hologic's breast cancer marking implant, after 71 reported injuries
FierceBiotech· 24 hours agoThe FDA is upgrading its safety warnings related to complications from Hologic’s implantable marker...
What to know about the blood test to detect colon cancer recommended by an FDA panel
ABC News via Yahoo News· 20 hours agoA blood test to screen for colorectal cancer is one step closer to receiving approval from the U.S....
FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
CNBC· 14 hours agoThe comments come after the FDA's staff on Wednesday flagged the risk of low blood sugar in type 1...
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...
Nearly 1.9 million cases of water impacted by FDA recall
KSNT Topeka via Yahoo News· 19 hours agoTOPEKA (KSNT) – The Food and Drug Administration (FDA) says a bottled water producer is recalling...
FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
The Norman Transcript· 9 hours agoAdvocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. Such groups have ...
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FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 1 day agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...