The company is preparing a Phase 3 trial of enobosarm with a novel formulation that could extend its patent life.

Commissioner Martin Makary and two of his deputies aim to meet with drugmaker CEOs to discuss how the agency can “modernize” ...

The percentage of adults prescribed a GLP-1 drug like Wegovy or Zepbound jumped almost sevenfold over the past five years, ...

The FDA has placed a clinical hold on the study while Rocket works with trial monitors and experts to investigate the cause ...

The acquisition expands Lilly’s pain pipeline with a slate of drugs targeting ion channel proteins like NaV1.7 and NaV1.8.

The agency recommends manufacturers update their vaccines to target the JN.1 strain. At the same time, HHS head Robert F.

As the pharmaceutical and biotech industries continue to innovate at a rapid pace, the demand for fill/finish capabilities ...

The startup is the latest beneficiary of investors’ appetite for protein-degrading technology, which offers a way to reach ...

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

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

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

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