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New Drug Application
Pharma
FDA cuts could put agency's user fee programs at risk: reports
Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to multiple reports.
Fraiser Kansteiner
Apr 4, 2025 11:00am
Tenpoint preps FDA filing after scoring in presbyopia study
Jan 9, 2025 3:39pm
Regulatory tracker: Bayer adds new Kerendia CV outcomes nod
Aug 29, 2022 9:48am
CorMedix hit with another CRL in effort to get nod for DefenCath
Aug 9, 2022 10:00am