The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their ...

Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New ...

Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung ...

Already a Vigil Neuroscience investor, Sanofi has agreed to buy the rest of the biotech’s shares for $8 apiece, representing a total deal value of $470 million.

The Danish drugmaker unveiled a series of initiatives to increase access to Wegovy and clamp down on use of the knock-off ...

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.

ReproNovo has licensed rights to two drugs from Mereo BioPharma and ObsEva that it thinks could address fertility issues in ...

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

Agency drug reviewers had questioned patient risk criteria and the efficacy endpoint used in a key trial supporting J&J's ...

The Swiss pharma has inked several collaborations in this field, suggesting it sees the approach as promising to rid the body ...

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

Tourmaline Bio disclosed results for a potential rival to a Novo Nordisk drug. Elsewhere, data emerged for a psychedelic and CRISPR Therapeutics expanded its toolkit.