Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.

ADLINK Technology today announced that its San Jose Manufacturing Center (SJMC), a California facility has secured ...

Trump and RFK Jr. plan to cut thousands of employees from the FDA and other agencies within the Department of Health and ...

DexCom receives a warning letter from the FDA citing several issues with its popular G6 & G7 sensor manufacturing. The ...

Soleno Therapeutics' FDA-approved drug for Prader Willi Syndrome triggers executive stock bonuses as the company's value ...

Enable Injections, Inc. ("Enable”), a healthcare innovation company developing and manufacturing the enFuse ® wearable drug ...

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

Today, the Dept. of Health and Human Services (HHS) announced “a dramatic restructuring” that will slash its total payroll by ...

While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...

Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...