Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Zacks.com on MSN4h
DexCom CGM Sensor Sales to Continue Despite FDA Warning LetterDXCM faces an FDA warning over manufacturing issues, but operations remain unaffected. However, supply-chain risks and rising ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
GlobalData on MSN2d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenueDexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
The FDA cited issues with DexCom’s response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7, 2024, ...
Novo Nordisk’s weight loss drug Wegovy is linked to an increased risk of hair loss, a study suggests. Meanwhile, Dexcom ...
A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...
BofA keeps a Buy rating on DexCom (DXCM) with a $105 price target after Dexcom announced it received a warning letter from the FDA.
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