To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

KCK-based Cingulate hires a top legal officer as it enters the home stretch of its effort to win FDA approval for a new drug.

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

Alvaro Fredy Córdoba Ruiz, the brother of the late Colombian politician Piedad Córdoba who is currently serving a 14-year sentence in the U.S. for drug trafficking, has offered a startling account of ...

The agency declined to quickly release documents that would identify drugs made at some of the most troubled foreign ...

Urine drug test (UDT) data can generate timely estimates of overdose deaths, a new study suggests. The study, published in JAMA Network Open by specialty lab Millennium Health and The Ohio State ...

U.S. drug deaths dropped by roughly 40% last year among people under the age of 35. It's a welcome pivot for families and communities devastated by fentanyl.

The leader of a drug organization that trafficked narcotics shaped like candy will spend nearly two decades behind bars, prosecutors said.

Commissioner Dr. Martin Makary’s recent decision to tap outspoken FDA critic, Dr. Vinay Prasad, as head of the Center for Biologics Evaluation and Research has brought the agency’s future into ...