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FDA warning letter

FDA
MedTech

Dexcom receives FDA warning letter over manufacturing issues

Dexcom has received a warning letter from the FDA, following two inspections of the diabetes tech company's facilities last year.
Conor Hale Mar 10, 2025 11:53am
Person holding a sign saying Help from behind a stack of paperwork and boxes

Applied CEO steps down in wake of FDA rejection, warning letter

Dec 20, 2024 12:51pm
Gavel on top of dollars

Lawsuit alleges Applied misled investors before FDA rejection

Dec 19, 2024 7:34am
Warning Letter FDA Warning Letter FDA

FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am
Cue Health COVID

UPDATE: Cue Health shuts down operations, lays off staff

May 22, 2024 2:15pm
FDA

J&J's Abiomed lands FDA warning letter over Impella heart pumps

Oct 13, 2023 10:42am

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