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 ...

Kinnate Biopharma, a biotechnology company focused on targeted cancer therapies, is reducing its workforce by 70%, leaving only 28 full-time employees as it adjusts research priorities. The layoffs ...

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 ...

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 ...

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

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