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BioMarin Pharmaceutical plans to resubmit a BLA for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A, by the end...[ Price : $8.95]
FDA extends by three months its review of a TG Therapeutics BLA for ublituximab, indicated for treating patients with relapsing fo...[ Price : $8.95]
Federal Register notice: FDA announces a 6/30 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss the curre...[ Price : $8.95]
Federal Register notice: FDA announces a 6/7 Vaccines and Related Biological Products Advisory Committee meeting to review Novavax...[ Price : $8.95]
Federal Register notice: FDA announces a 6/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss ex...[ Price : $8.95]
FDA warns OsteoLife Biomedical about regulatory deviations in its processing of human cells, tissues, and cellular- and tissue-bas...[ Price : $8.95]
CDRH says it will resume processing non-Covid in vitro diagnostic pre-submissions, but generally with an extended timeline.[ Price : $8.95]
Researchers from Harvard University and other organizations make the case for a distributed approach to regulating clinical artifi...