Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

"Recent adjustments in staff numbers have created a heightened need for the FDA to be nimble, efficient and respond creatively, in order to continue and maintain FDA's regulatory inspection ...

Here is a roundup of March 2025 U.S. FDA approvals across cancer subtypes, including prostate, bladder and gastrointestinal ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...

This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

“Leadership in the agency’s been decapitated, and I think that was somewhat deliberate,” Janet Woodcock, M.D., former acting ...

Key to 400-employee Denali's submission is the FDA allowing measurement of a type of GAG, called heparan sulfate, in ...

AstraZeneca‘s IMFINZI® (durvalumab) has gained FDA approval for use in adult patients with muscle-invasive bladder cancer ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...