The FDA
accepts for review Sarepta Therapeutics’ (NASDAQ:
SRPT) marketing application seeking approval of casimersen (SRP-4045), branded as AMONDYS 45, for the treatment of Duchenne muscular dystrophy (DMD) patients amenable to exon 45 skipping.
At this point, no advisory committee meeting is planned.
The agency’s action date is February 25, 2021.
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