FDA publishes redacted versions of over 200 complete response letters issued between 2020 and 2024 in a demonstration of its commitment to radical tra...
FDA commissioner Martin Makary takes a 100-days-in-office victory lap, citing 32 initiatives that he says have been started to Make America Healthy Ag...
FDA accepts for review a Merck NDA for its investigational once-daily HIV treatment combining doravirine and islatravir.
The Senate Committee on Appropriations votes to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Development, FDA and Relat...
FDA approves a Moderna sBLA for its Spikevax Covid-19 vaccine for children aged six months to 11 years old who are at increased risk for Covid-19.
Rhythm Pharmaceuticals reports positive topline results from its Phase 2 trial evaluating bivamelagon in patients with acquired hypothalamic obesity.
FDA clears an Exactech 510(k) for the Equinoxe Scapula Reconstruction System for treating acromial and scapular spine fractures.
A Washington federal judge says FDA acted lawfully in imposing restrictions on the availability of chemical abortion drugs mifepristone and misoprosto...
