The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...

Biocryst is offloading part of its business for $250 million. Meanwhile, the former FDA leader took issue with a new policy ...

Thimerosal, targeted by activists who claim it’s linked to autism, shouldn't be used in vaccines administered in the U.S. in the coming flu season, the CDC panel said.

The brain drug developer is now saying that its two marketed products could ultimately bring in $2 billion annually, and its ...

Bill Meury, who shepherded Karuna and Anthos to multibillion-dollar buyouts, will take over Incyte, a successful drug ...

By a 5-2 vote, the Advisory Committee on Immunization Practices endorsed Merck’s Enflonsia for babies born during or entering ...

New members of the ACIP panel raised questions about the evidence supporting COVID vaccines, and signaled plans to look at ...

The GOP senator objected to Secretary Kennedy's recasting of the influential advisory panel, which has sparked criticism from ...

The Trump administration aims to issue a rule empowering regulators to “forcefully” go after companies that don’t share drug ...

Full Phase 2 study results showed side effects that led people to stop treatment with MariTide, as well as weight loss ...

The biotech will work on molecular glue degraders with Gilead in a new deal. Existing partner Sanofi changed its focus to a ...

Jaqueline Corrigan-Curay, who serves as acting head of the FDA’s Center for Drug Evaluation and Research, will depart next ...