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FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
CNBC· 1 day agoThe comments come after the FDA's staff on Wednesday flagged the risk of low blood sugar in type 1...
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 advisers weigh benefits of weekly insulin for people with diabetes
CNN via Yahoo News· 1 day agoMost types of insulin therapy, an important part of diabetes treatment for many people, are given as...
FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 2 days agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...
JD Supra: CMS Proposes Important Enhancements to the New Technology Add-on Payment Program in the FY...
JD Supra· 5 hours agoProposals include increasing the number of manufacturers eligible for a full three years of NTAP, determining those applicants in a “hold status” with the FDA will no longer ...
FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
The Norman Transcript· 21 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 ...
US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
Reuters via Yahoo News· 1 day agoNovo is aiming to be the first to hit the market with a weekly insulin product, offering an...
FDA lifts partial clinical hold on Larimar’s Friedreich’s ataxia treatment
Endpoints News· 5 days agoLarimar Therapeutics’ stock $LRMR shot up by as much as 20% after announcing Monday that the FDA had...
FDA advisory committee says risks of Novo Nordisk’s once-weekly insulin outweigh benefits in type 1...
Endpoints News· 1 day agoAn FDA advisory committee on Friday voted not to recommend Novo Nordisk’s once-weekly insulin...
Guardant Health Jumps — As Exact Sciences Slumps — On A Key FDA Move For Blood Tests
Investor's Business Daily· 1 day agoGuardant Health stock jumped Friday after a Food and Drug Administration panel recommended the...