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 patients while it evaluates new safety precautions.

Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a ...

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

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

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

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 ...

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

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

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