While the agency cleared vaccines from Pfizer, Moderna and Novavax broadly in older adults, it restricted eligibility in younger people to those with...

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the drug approv...

Stealth secured a new agency review of its experimental therapy elamipretide after a rejection this year. The result could carry broader consequences.

Cemdisiran helped control symptoms of generalized myasthenia gravis, but combination treatment with a Regeneron antibody didn't appear as effective.

In people with diabetes and obesity, orforglipron led to weight loss near what people without diabetes experienced in prior testing.

Biopharmaceutical firms in the U.S. and Europe are turning to China’s biotech sector for new medicines, with licensing hitting a record pace in 2025....

The asset deal thrusts AbbVie to the forefront of the psychedelic field, handing it a therapy that recently scored positive Phase 2 results in major d...

The agency said it had become aware of more reports of serious adverse events, leading center director Vinay Prasad to conclude the vaccine is no long...

An $885M deal with BeOne Medicine gives the pharma financier rights to a revenue stream from global sales of Imdelltra, which is sold by Amgen.

Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff in Maryland.