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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...
What to know about the blood test to detect colon cancer recommended by an FDA panel
ABC News via Yahoo News· 19 hours agoA blood test to screen for colorectal cancer is one step closer to receiving approval from the U.S....
FDA upgrades safety alert for Hologic's breast cancer marking implant, after 71 reported injuries
FierceBiotech· 23 hours agoThe FDA is upgrading its safety warnings related to complications from Hologic’s implantable marker...
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 panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
CNBC· 13 hours agoThe comments come after the FDA's staff on Wednesday flagged the risk of low blood sugar in type 1...
FDA advisers weigh benefits of weekly insulin for people with diabetes
CNN via Yahoo News· 17 hours agoMost types of insulin therapy, an important part of diabetes treatment for many people, are given as...
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· 8 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 Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 3 days agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
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,...