The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade ...

Commissioner Marty Makary said FDA employees are overseeing the use of AI, but questions remain about how the technology will be applied amid staff cuts.

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) plan to phase out all ...

A U.S. senator is asking the FDA how it will enforce regulations on pharmaceutical advertising after it let go of numerous ...

Health and Human Services Secretary Robert F. Kennedy Jr. on Tuesday announced the removal of the COVID-19 vaccine from the ...

This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no ...

French drugmaker Sanofi said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

The Food and Drug Administration has opened the door to cut costs and pain for those who suspect they have Alzheimer’s ...

Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter ...

The FDA is embracing natural colorants, with three approvals meant to replace synthetic dyes. Galdieria extract, butterfly ...

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...