Go or no go? A busy month ahead for US FDA decisions
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 comes to Boston for the springtime
Karyopharm’s newly approved myeloma drug, Xpovio, has shown promise in earlier lines of therapy, but toxicity could still cap its potential.
Upcoming events – Karyopharm's myeloma expansion and Pfizer's biz dev nous
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…
Biogen leads the way in renewed amyotrophic lateral sclerosis push
The company has quietly emerged as the key player to watch in an area that has seen several setbacks of late.
Novel drug approvals head for a down year
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.
Karyopharm rollercoaster ends in selinexor approval
Positive data, toxicity, a US FDA delay and the early leaking of information culminate in a green light for the multiple myeloma drug.
Go or no go? Karyopharm awaits a verdict on selinexor
A delayed decision on Karyopharm’s selinexor is the pick of the bunch for July.
Adcom gives Karyopharm a second chance with selinexor
Incredibly, a US FDA panel has left the door open for approval of Karyopharm’s selinexor in multiple myeloma, despite concerns about safety.
