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In its second biennial report required by the 21st Century Cures Act, FDA says that software not considered a medical device gener...[ Price : $8.95]
FDA says it will review the Samsung Bioepsis/Biogen BLA for a biosimilar of Genentechs Lucentis.[ Price : $8.95]
Omeros completes a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic mi...[ Price : $8.95]
CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar...[ Price : $8.95]
CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.[ Price : $8.95]
CDER researchers say adding a CDK 4/6 inhibitor to hormonal treatment helps some metastatic breast cancer patients.[ Price : $8.95]
FDA announces a 1/26 virtual workshop on non-clinical assays for comparative immunogenicity risk assessment for generic peptide pr...