A federal register notice confirmed dates for the anticipated advisory meeting, which will follow an FDA decision to narrow COVID boosters' approval and comes as CDC leadership is in turmoil.

The agreement provides research funding for Replicate and up to $550M in payments to develop medicines for diseases including obesity and diabetes.

While the agency cleared vaccines from Pfizer, Moderna and Novavax broadly in older adults, it restricted eligibility in ...

Treatment with Verzenio helped people with a common type of early breast cancer liver longer than those given standard ...

AMX0035 missed the goals of a study in progressive supranuclear palsy. Elsewhere, Novartis and BioArctic struck a deal, and Genentech started building its first East Coast factory.

The St. Louis-based biotech hopes to submit an application for its leukemia and lymphoma therapy in 2027, if all goes well in ...

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

Cemdisiran helped control symptoms of generalized myasthenia gravis, but combination treatment with a Regeneron antibody didn ...

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

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