BXCL501 met the main goal in a Phase 3 trial for agitation in bipolar and schizophrenia patients. FDA filing for at-home Igalmi use expected in the first quarter of 2026 following trial success. Get ...

(NEXSTAR) – A pair of sweeteners are being recalled nationwide due to a labeling mishap, according to the Food and Drug Administration (FDA). The Oregon-based company known for its sugar-free ...

The Food and Drug Administration on Thursday lifted its recommendation to pause use of Valenva’s chikungunya vaccine Ixchiq in older adults, but added new warnings about the shot’s risks and limited ...

Teva Pharmaceutical (NYSE:TEVA) announced on Wednesday that the U.S. Food and Drug Administration (FDA) approved its migraine therapy Ajovy for children and adolescents, expanding its previous label ...

The FDA is requiring manufacturers of opioid pain medications to update safety labels to better emphasize risks linked to their long-term use, the agency announced in a new Drug Safety Communication.

The FDA is requiring safety labeling changes to all opioid painkillers, to better highlight the risks posed by using the drugs long-term. The changes come after a public advisory committee meeting in ...

Findings from postmarketing studies showed long-term opioid use was associated with serious risks including misuse, addiction, and overdose. The Food and Drug Administration (FDA) is requiring ...

ABC News' Dr. Darien Sutton breaks down the FDA's new labeling rules aimed at addressing long-term use and addiction risks. ‘Grow up’: Republican Senators slam Trump for firing labor statistics chief ...

The US FDA will require drugmakers to submit updated opioid labeling within 30 days for review, aiming to better reflect long-term use risks including addiction and overdose. FDA sent letters to ...

The FDA is revising the labeling of all extended-release attention-deficit/hyperactivity disorder (ADHD) medications, including certain formulations of amphetamine ...