Keeping Track: US FDA Approval Of Jazz Rylaze Addresses Shortage; MediWound, Cyclopharm Receive CRLs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Changing therapeutic landscape may have complicated regulatory plans for Regeneron/Sanofi’s PD-1 inhibitor in second-line cervical cancer, while accelerated approval confirmatory trial timeline appears to have been an issue for Incyte’s PI3-kinase inhibitor in lymphoma.
Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.
The European Medicines Agency has added seven new products to its list of medicines that are under review for potential EU marketing authorization.