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BioMarin Resubmitting Hemophilia A BLA in September

[ Price : $8.95]

BioMarin Pharmaceutical plans to resubmit a BLA for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A, by the end...

FDA Extends Review of Multiple Sclerosis Therapy

[ Price : $8.95]

FDA extends by three months its review of a TG Therapeutics BLA for ublituximab, indicated for treating patients with relapsing fo...

Panel to Discuss Xenotransplantation Regulatory Issues

[ Price : $8.95]

Federal Register notice: FDA announces a 6/30 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss the curre...

Panel to Discuss Novavax Covid-19 Vaccine

[ Price : $8.95]

Federal Register notice: FDA announces a 6/7 Vaccines and Related Biological Products Advisory Committee meeting to review Novavax...

Panel to Review Expanded Use of Covid Vaccines

[ Price : $8.95]

Federal Register notice: FDA announces a 6/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss ex...

HCT/P Deviations Seen in OsteoLife Inspection

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FDA warns OsteoLife Biomedical about regulatory deviations in its processing of human cells, tissues, and cellular- and tissue-bas...

CDRH Resuming Non-Covid IVD Pre-Submission Reviews

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CDRH says it will resume processing non-Covid in vitro diagnostic pre-submissions, but generally with an extended timeline.

A Distributed Approach to Regulating Clinical AI

[ Price : $8.95]

Researchers from Harvard University and other organizations make the case for a distributed approach to regulating clinical artifi...

Approval Withdrawn for TG Therapeutics Ukoniq

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of TG Therapeutics NDA for Ukoniq (umbralisib tosylate) tablets based on a company...

Panel to Discuss Modified Covid-19 Vaccine

[ Price : $8.95]

Federal Register notice: FDA announces a 6/28 Vaccines and Related Biological Products Advisory Committee meeting to discuss modif...