Fauci: Concerns About Exclusive Licensing Of Government-Developed Products Are Misguided
NIAID director says granting exclusive licenses to drug companies is necessary for late-stage development and production of government-developed products.
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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.