FDA Makes First-Ever Flu Strain Selection For Southern Hemisphere Vaccine
Sanofi gets its manufacturing roadmap as advisory committee supported WHO's preferred trivalent and quadrivalent formulations in separate 14-0 votes.
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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.