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FDA warning letter
Biotech
FDA chides Applied Therapeutics' trial conduct in warning letter
While Applied Therapeutics plans to appeal a recent rejection of govorestat, issues with the biotech’s clinical conduct could hamper those plans.
Fraiser Kansteiner
Dec 4, 2024 11:21am
UPDATE: Cue Health shuts down operations, lays off staff
May 22, 2024 2:15pm
J&J's Abiomed lands FDA warning letter over Impella heart pumps
Oct 13, 2023 10:42am
FDA warns Integra on Boston facility's 'adulterated' devices
Aug 17, 2023 12:15pm
Outset Medical halts TabloCart shipments after FDA warning
Aug 7, 2023 10:15am
Outset Medical hit with FDA warning letter
Jul 10, 2023 11:43am
