Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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BridgeBio, Helsinn Partner Again After Truseltiq Success
Deal Snapshot: The two firms will seek to co-develop and co-commercialize targeted small molecule cancer therapies that they identify at the preclinical stage.
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.
US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.