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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Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.
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.
With US FDA approval of Wegovy for obesity, Novo Nordisk prices the weekly injectable at par with its other obesity brand Saxenda. Ramping up sales will require patient, clinician and payer education, the company says.