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 ...

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 ...

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

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

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

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

The startup, which is backed by the venture arms of Sanofi, Roche and Novartis, is using dual adeno-associated viruses to ...

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

Valued at $1.25 billion, the deal expands BioNTech’s cancer drug portfolio and heads off royalty costs it could have owed ...