Sarepta Scores Another Remarkable Approval With Vyondys 53 For Duchenne
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.
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Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.
CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.
Brett Giroir’s tenure as acting commissioner of the US FDA won’t last long, but it has marked another high water mark in the pro-innovation climate at the agency, which is an important message about what FDA commissioners do – and don’t – actually do.