Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.
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Karyopharm says its treatment for patients with refractory multiple myeloma could become its first product to be approved in Europe.
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Keeping Track: Approvals For Phexxi, Kynombi; New Claims For Lynparza, Alunbrig, Tecentriq; Intercept May Miss NASH User Fee Date
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.