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 patients while it evaluates new safety precautions.

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

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 ...

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

The drug, Ibtrozi, will now vie for market share in an indication where multiple large pharmaceutical companies have already ...

Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly ...

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

A "sub-study" of a large clinical trial found the drug, obicetrapib, significantly reduced levels of a type of tau protein ...

The chronic condition management company’s debut comes weeks after another digital health company, Hinge Health, went public.

The startup, which has raised more than $2 billion in funding to aid young biotechs with drug production, said its “capacity ...

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