Posted by Michael Wonder on 18 Feb 2024
Sarepta Therapeutics announces US FDA acceptance of an efficacy supplement to expand the Elevidys indication
16 February 2024 - Priority review granted, with a review goal date of 21 June 2024.
Sarepta Therapeutics today announced the US FDA has accepted and filed the Company's efficacy supplement to the biologics license application for Elevidys (delandistrogene moxeparvovec-rokl).
