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.
You may also be interested in...
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
BARDA and Development Financing Corp. officials provide insights into window of opportunity for partnering on manufacturing scale-up.
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.