FDA warning letter

FDA
MedTech

FDA slams ExThera with warning letter for blood filter device

The FDA slammed ExThera with a warning letter for promoting and selling its Seraph 100 blood filter device to treat cancer patients.
Joseph Keenan Feb 27, 2026 8:55am
Abbott sign

Abbott hit by quality violations from FDA over CGM products

Feb 4, 2026 9:25am
FDA

Dexcom receives FDA warning letter over manufacturing issues

Mar 10, 2025 11:53am
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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
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FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am