Revamped Manufacturing Process Yields Fast-Track Ryplazim Approval Three Years Later
Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.
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Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
FlexBiosys wins award; others to follow. New capacity may also benefit manufacture of monoclonal antibodies and cell and gene therapies.
US FDA is looking at risk-based approach for reporting changes in out-of-stock components such as plastic bioreactor bags, filters and tubing sets that are in short supply.