FDA says it will review the Samsung Bioepsis/Biogen BLA for a biosimilar of Genentechs Lucentis.
Omeros completes a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy.
FDA delays the PDUFA action date to complete review of a BMS BLA for liso-cel to treat some large B-cell lymphomas due to the pandemic.
FDA grants Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can be performed entire...
Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.
CDER researchers say adding a CDK 4/6 inhibitor to hormonal treatment helps some metastatic breast cancer patients.
FDA announces a 1/26 virtual workshop on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products.
FDA commissioner Stephen Hahn says the agency is posting scientific review materials relating to emergency use authorization actions taken by FDA, as ...