The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market ...

The funds will support Phase 2 testing of a drug the company believes to be able to safety home in on AMPA receptors, an ...

While the results were an important proof point for so-called anti-myostatin drugs, Scholar Rock executives indicated the ...

With backers such as Regeneron’s venture arm, Actio Biosciences is working on medicines that counter a wide range of ...

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 ...