FDA Makes First-Ever Flu Strain Selection For Southern Hemisphere Vaccine
Executive Summary
Sanofi gets its manufacturing roadmap as advisory committee supported WHO's preferred trivalent and quadrivalent formulations in separate 14-0 votes.
You may also be interested in...
Sanofi-Pasteur's Southern Strategy Gets Its Own FDA Advisory Committee
Fluzone remains only flu vaccine on US market with an FDA-approved southern formulation.
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.
Xpovio Clinical Development Timeline
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.