Despite FDA warnings and no U.S. approval, underground brands keep marketing tianeptine products like Zaza and Tianaa, ...

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

The Food and Drug Administration is urging consumers to “stop using it immediately” if they have any of the affected lots of ...

We look at the continued turmoil within the FDA, including the forced dismissal of top gene therapy regulator Nicole Verdun, as well as the announcement of a controversial drug-review voucher program ...

It took as little as five minutes to order abortion pills opponents argue are unsafe without a doctor adequately verifying ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

The Food and Drug Administration is sounding the alarm regarding the substance Tianeptine, sometimes referred to as “gas station heroin.” ...

Little Remedies® Honey Cough Syrup was voluntarily recalled due to the presence of Bacillus cereus, which can cause two types ...

The FDA approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show ...

The U.S. Food and Drug Administration this week approved Gilead Sciences’ twice-a-year shot, lenacapvir, to prevent HIV, Gilead announced on Wednesday, June 18. It is the first and only long-acting ...

The Food and Drug Administration has approved a new injectable drug that can help prevent HIV. Dr. Amesh Adalja, a senior ...