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...
FDA grants accelerated approval for BeiGenes Brukinsa (zanubrutinib) for treating adult patients with relapsed or refractory marginal zone lymphoma.
FDA reminds healthcare providers that some fluid warmers can leach aluminum into the fluids or blood products being administered to patients.
FDA creates an Office of Digital Transformation, reporting to the commissioner, as part of its ongoing information technology and data modernization e...