In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

The Food and Drug Administration is considering adding warning labels to antidepressants for people who are pregnant, despite ...

Supporters argue it is a safer, natural alternative to opioids. But critics and regulators warn about the risks of dependence ...

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Dozens of lawmakers are urging U.S. health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion ...

Powerful new medications such as Ozempic and Mounjaro, known as GLP-1 drugs are helping to win the war against obesity in ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

It's since become popular in the United States. Haddow, with the American Kratom Association, said more than 24 million ...

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater ...