FDA accepts for priority review an Athenex NDA for oral paclitaxel and encequidar for treating metastatic breast cancer.
FDA grants Alphamab Oncology an orphan drug designation for KN046, a recombinant humanized antibody for treating thymic epithelial tumors.
Aerospace engineer Robert Zubrin writes in National Review that FDA is an over-regulating federal bureaucracy gone mad.
FDA commissioner Stephen Hahn removes associate commissioner for external affairs John Wagner as part of the purge to right the ship in the wake of Ha...
An NIH Covid-19 treatment guideline panel refutes FDAs recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treat...
Mylan recalls four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-u...
Three stakeholders say FDA should provide additional clarification on the rules for listing patents in the Orange Book.
Federal Register notice: FDA determines that KV Pharmaceuticalֺs Micro-K LS (potassium chloride) extended-release liquid suspension, 20 milliequ...