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Researchers in the UK and Italy say the use of surrogate endpoints in drug regulation should be tightened.[ Price : $8.95]
Three Cooley attorneys say a recent Court of Appeals for the Federal Circuit decision shows how giving inconsistent information to...[ Price : $8.95]
FDA extends by three months the review of a Calliditas Therapeutics NDA seeking accelerated approval for Nefecon (budesonide) for ...[ Price : $8.95]
FDA and the European Medicines Agency launch a pilot program to provide parallel scientific advice to ANDA and MMA applicants for ...[ Price : $8.95]
Amid controversy over whether Covid-19 vaccine booster shots are needed, the FDA Vaccines and Related Biological Products Advisory...[ Price : $8.95]
Amylyx Pharmaceuticals plans to submit an NDA in the coming months for AMX0035 (sodium phenylbutyrate and taurursodiol) for treati...[ Price : $8.95]
FDA grants accelerated approval for BeiGenes Brukinsa (zanubrutinib) for treating adult patients with relapsed or refractory margi...[ Price : $8.95]
FDA reminds healthcare providers that some fluid warmers can leach aluminum into the fluids or blood products being administered t...