A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug ...

The data could help the Enhertu regimen overtake a drug combination that’s been used as the initial treatment for ...

Alis Biosciences says its goal is to return to investors billions of dollars stuck on the balance sheets of “moribund” ...

The leaked budget draft, if approved by Congress, would reduce the FDA’s budget authority, indicating more disruption could ...

Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as ...

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales ...

U.K. regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, an investment firm pressed Elevation Oncology to liquidate and the FDA relaxed risk monitoring ...

The drug, orforglipron, helped people with diabetes reduce their blood sugar levels while spurring significant weight loss, ...

The startup, affiliated with China-based antibody designer Helixon Therapeutics, is developing bispecific drugs aimed at ...

The company’s board reiterated its recommendation to instead pursue an offer from SK Capital and Carlyle that’s worth about ...

The committee endorsed lowering the age at which some people can receive RSV vaccines, but stopped short of recommending ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.