Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe.
Janssen Pharmaceutical files a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma.
FDA grants Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) Alzheimers Disease...
FDA seeks feedback on a discussion paper entitled Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.
Federal Register notice: FDA withdraws approval of 35 NDAs at the request of their sponsors.
FDA adopts an international guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.
Federal Register notice: FDA makes available a final guidance entitled Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.
Federal Register notice: FDA determines that Norflex (orphenadrine citrate) injection and extended-release tablets were not withdrawn from sale for re...
