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FDA warning letter
Biotech
Applied CEO steps down in wake of FDA rejection, warning letter
CEO Shoshana Shendelman, Ph.D., was named in a recent lawsuit along with the company's chief medical officer and the biotech itself.
Darren Incorvaia
Dec 20, 2024 12:51pm
Lawsuit alleges Applied misled investors before FDA rejection
Dec 19, 2024 7:34am
FDA chides Applied Therapeutics' trial conduct in warning letter
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
