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FDA upgrades safety alert for Hologic's breast cancer marking implant, after 71 reported injuries
FierceBiotech· 21 hours agoThe FDA is upgrading its safety warnings related to complications from Hologic’s implantable marker...
Mirat Shah, MD, on Elacestrant's FDA Approval for Breast Cancer With ESR1 Mutations
MedPage Today· 4 days agoFDA scientists published a detailed rationale for the approval of elacestrant (Orserdu), the first...
What to know about the blood test to detect colon cancer recommended by an FDA panel
ABC News via Yahoo News· 17 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· 11 hours agoThe comments come after the FDA's staff on Wednesday flagged the risk of low blood sugar in type 1...
Nearly 1.9 million cases of water impacted by FDA recall
KSNT Topeka via Yahoo News· 16 hours agoTOPEKA (KSNT) – The Food and Drug Administration (FDA) says a bottled water producer is recalling...
FDA advisers weigh benefits of weekly insulin for people with diabetes
CNN via Yahoo News· 15 hours agoMost types of insulin therapy, an important part of diabetes treatment for many people, are given as...
Guardant Health Jumps — As Exact Sciences Slumps — On A Key FDA Move For Blood Tests
Investor's Business Daily· 16 hours agoGuardant Health stock jumped Friday after a Food and Drug Administration panel recommended the...
FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
The Norman Transcript· 5 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 ...
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
BioPharma Dive via Yahoo Finance· 24 hours agoBut the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening...
FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 1 day agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...