EQS-News: Nyxoah SA. / Key word (s): Miscellaneous FDA Issues Nyxoah an Approvable Letter for its Genio® System 26.03.2025 / 09:45 CET/CEST The issuer is solely responsible for the content of this ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...

DexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024. The FDA cited deficiencies in the company’s manufacturing ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections of the company’s facilities in San Diego ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...

March 7 (Reuters) - Medical device maker Dexcom (DXCM.O), opens new tab said it has received a warning letter from the U.S. Food and Drug Administration following inspections of its two key ...

Roll Call first reported on the lawmakers' letter late last week. The FDA is funded in part by user fees, a program that allows the agency to collect money from companies that submit applications ...

is pleased to announce today that the Company has received an Amendment Acknowledgement Letter (“AAL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application for ...

Bengaluru: Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following inspections of its two key manufacturing facilities, sending its ...