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, ...

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 ...

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

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

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

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

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

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s ...