FDA says Biomea Fusion can start a Phase 1 trial of its BMF-219 in some leukemia patients.
FDA clears a Gynesonics 510(k) for the (XXXX DELETE XXX) Sonata System 2.2 for treating fibroids.
FDA expands an Eli Lilly emergency use authorization for bamlanivimab 700 mg and etesevimab 1,400 mg administered together to provide post-exposure pr...
Researchers in the UK and Italy say the use of surrogate endpoints in drug regulation should be tightened.
FDA extends by three months the review of a Calliditas Therapeutics NDA seeking accelerated approval for Nefecon (budesonide) for treating primary IgA...
FDA and the European Medicines Agency launch a pilot program to provide parallel scientific advice to ANDA and MMA applicants for complex generic drug...
Amid controversy over whether Covid-19 vaccine booster shots are needed, the FDA Vaccines and Related Biological Products Advisory Committee meets 9/1...
Amylyx Pharmaceuticals plans to submit an NDA in the coming months for AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic later...