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

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

While the results were an important proof point for so-called anti-myostatin drugs, Scholar Rock executives indicated the ...

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

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

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, ...

The Swiss drugmaker said it was “encouraged” by the signs of effectiveness of the drug, developed by biotech Prothena, showed ...

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

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

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

The Danish drugmaker, which is grappling with a share decline and competition from Eli Lilly, unveiled planned trials of an ...