BioMarin Pharmaceutical plans to resubmit a BLA for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A, by the end of September that w...
FDA extends by three months its review of a TG Therapeutics BLA for ublituximab, indicated for treating patients with relapsing forms of multiple scle...
Federal Register notice: FDA announces a 6/30 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss the current regulatory expect...
Federal Register notice: FDA announces a 6/7 Vaccines and Related Biological Products Advisory Committee meeting to review Novavaxs Covid-19 vaccine a...
Federal Register notice: FDA announces a 6/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss expanded pediatric use...
FDA warns OsteoLife Biomedical about regulatory deviations in its processing of human cells, tissues, and cellular- and tissue-based products.
CDRH says it will resume processing non-Covid in vitro diagnostic pre-submissions, but generally with an extended timeline.
Researchers from Harvard University and other organizations make the case for a distributed approach to regulating clinical artificial intelligence.