Humacyte, Inc.
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Latest on Humacyte, Inc.
The median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug User Fee Act goals, highlighting the fundamental predictability of the re
The US Food and Drug Administration’s September will probably look quiet after August 2024 produced seven novel approvals and two complete response letters, but should still be interesting. As many as
Syndax Pharmaceuticals’ Revumenib PDUFA for NDA – First Review 26 September A new opportunity is opening up in a rare subset of patients with acute leukemia – those with KMT2A rearrangements. Synda
A string of complete response letters from the US FDA clouded the 2024 outlook for novel cancer therapies, but a productive pipeline is carrying enough candidates towards second half user fee goal dat