FDA approves an expanded label for Mercks Keytruda (pembrolizumab) as monotherapy for treating certain patients with locally advanced cutaneous squamo...
FDA denies all but one request in a Celgene/Abraxis 2015 petition involving Abraxane.
FDA clears the UVision 360 Luminelle biopsy sheath for uterine and bladder biopsies.
FDA clears a Siemens Healthineers 510(k) for the Magnetom Free Max, a new High-V magnetic resonance scanner.
FDA revokes emergency use authorizations for all non-NIOSH-approved disposable respirators and decontamination and bioburden reduction systems.
FDA says Teva has recalled one lot of its topotecan injection following a complaint about foreign particles in one vial.
FDA issues a guidance with recommendations on an alternate electronic format for some submissions to CDER and CBER.
ChemoCentryx files an amendment to its NDA for avacopan for treating anti-neutrophil cytoplasmic autoantibody-associated vasculitis to address advisor...