The approval was based on data from a Phase II trial, two retrospective chart review studies and an expanded access programme ...

The administration, as well as HHS, publicly praised Marty Makary’s leadership despite persistent upheaval at the agency.

An alleged extortion attempt, a petty yearslong grudge, shocking social media posts, and ominous text messages make up the ...

It was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months. In interviews, ...

Dr. George Tidmarsh, who joined the FDA in July, stepped down Sunday, The New York Times reported. His resignation came just ...

The latest turmoil within Commissioner Marty Makary’s Food and Drug Administration, an alleged bribery scandal involving a high-level official, is no anomaly. The Sunday resignation of the Center for ...

Aurinia alleges that Tidmarsh’s statements were not only inaccurate but also motivated by a personal vendetta against Kevin ...

The U.S. Food and Drug Administration recalled more than 580,000 bottles of a blood pressure medication. Is your medication ...

Developers of biosimilars will no longer be required by the FDA to conduct clinical trials to prove effectiveness.

The Utah Dental Association (UDA) has issued an urgent guidance days after the U.S. Food and Drug Administration (FDA) moved to limit the use of fluoride supplements used to strengthen children’s ...

First and Last Bakery, LLC recalled tomato sauce sold in two states over botulism concerns. Here's what to know.