A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committee.
FDA approves a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize 10 years of new chemical entity exclu...
Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to ...
Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mu...
FDA says a Draeger recall of breathing circuit components is Class 1.
FDA publishes the International Council on Harmonization technical representation of its M11 guideline protocol template.
The House Appropriations Committee posts FDAs budget bill for FY 2026 that mirrors the Trump Administrations budget proposal that would decrease the a...
FDA grants platform technology designation to a Sarepta viral vector used in an investigational gene therapy to treat a form of muscular dystrophy.
