Stakeholders suggest changes to an FDA draft guidance on including geriatric information in drug labeling.
In its second biennial report required by the 21st Century Cures Act, FDA says that software not considered a medical device generally provides more b...
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...
CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar User Fee reauthoriz...
CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment pilot project that ...