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

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

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

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 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 ...

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

Days after firing all 17 members of the CDC's Advisory Committee for Immunization Practices, the HHS Secretary named a small ...

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

AstraZeneca could spend up to $5.3 billion in a deal to develop oral medicines with CSPC Pharmaceutical. Elsewhere, Insmed ...

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