June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular…
Karyopharm’s newly approved myeloma drug, Xpovio, has shown promise in earlier lines of therapy, but toxicity could still cap its potential.
Karyopharm hopes to move Xpovio earlier in the multiple myeloma treatment sequence, and data are due for Akcea/Ionis’s triglyceride regulator, for which Pfizer paid a…
The company has quietly emerged as the key player to watch in an area that has seen several setbacks of late.
With only 18 novel drugs approved by the FDA so far this year, the influential US regulator looks set to dim the green lights in 2019.
Positive data, toxicity, a US FDA delay and the early leaking of information culminate in a green light for the multiple myeloma drug.
A delayed decision on Karyopharm’s selinexor is the pick of the bunch for July.
Incredibly, a US FDA panel has left the door open for approval of Karyopharm’s selinexor in multiple myeloma, despite concerns about safety.