Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities.

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...

Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat, which was rejected by the agency last week. The letter – addressed ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

Click in for more news from The Hill{beacon} Health Care Health Care   The Big Story Top FDA official’s exit sends ripples ...

The U.S. Food and Drug Administration has warned Aspen Pharmacare ... medicines that require sterile production. In a Feb. 24 warning letter, released publicly Tuesday, the agency noted that ...

FDA rejects all in vitro study data from Raptim Research due to data falsification, requiring companies to redo studies ...

Aspen, the largest drugmaker on the African continent, was slammed last month in a warning letter by the FDA citing sterility issues that could lead to microbial contamination. The FDA posted the ...

The Food and Drug Administration warned a California cannabis company on Monday that its injectable hemp CBD could be posing “serious harm” to public health, telling the company that its ...

The FDA’s warning came after reports over the past ... to these IL-1 and IL-6 inhibitors,” she said. (Provider letters have asked prescribers to inform patients of the risk and to consider ...