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

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

Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice ...

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

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

Orthocell receives US FDA 510(k) approval for Remplir, its flagship nerve repair product and can now start commercial ...

LONDON (Reuters) -Trump administration cuts across federal health agencies have sent shivers through a biotech industry ...

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

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

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

The U.S. Supreme Court on Wednesday largely backed the U.S. Food and Drug Administration's refusal to let two e-cigarette ...