STAT June 21, 2024
Jason Mast, Matthew Herper

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy.

On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article