The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and ...

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

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

The Outsourcing Facilities Association is appealing a ruling that rejected their request for an injunction against the FDA’s ...

Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.

"I was expecting him probably to win. It was very big win," Pfizer's CEO Albert Bourla said of President Donald Trump's ...