Brazil's Anvisa Enjoys Industry Support Despite Regulatory Changes, Low Funding
Brazil's regulatory agency must now approve drug applications in specified timeframes, despite lack of resources; industry nevertheless sees a bright future for Anvisa and other agencies in region.
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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.
Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.
Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.