A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or ...

The funds will support Phase 2 testing of a drug the company believes to be able to safety home in on AMPA receptors, an ...

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market ...

With backers such as Regeneron’s venture arm, Actio Biosciences is working on medicines that counter a wide range of ...

The deal centers around a medicine that could “shift the treatment paradigm for cardiovascular disease,” Lilly said, but also ...

The agency cleared CSL’s hereditary angioedema drug days after “resource constraints” delayed a rival medicine. Elsewhere, ...

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...

Five months after selling a cancer drug to Lilly for up to $2.5 billion, Scorpion has debuted a successor company led by its ...

Enlicitide, which could be the first oral medication that blocks the protein PCSK9, helped cut cholesterol levels in a pair ...

The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned ...

In what one analyst described as an “unremarkable” outcome, the brain drug developer is being acquired for just $8.50 per ...

Another person treated with Elevidys suffered acute liver failure, leading Sarepta to discontinue treatment in certain ...