Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

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.