Applied Therapeutics (APLT) announced an update on the ongoing New Drug Application review of govorestat for the treatment of Classic Galactosemia. The PDUFA target action date remains on track for November 28, 2024. The FDA informed the company that the Priority Review of the NDA is continuing as planned with alignment on post-marketing requirements expected in October 2024.
The FDA has communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.