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Latest From Prometic Biotherapeutics
US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development
Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
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.
Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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
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