The FDA has assigned a six-month review period for the resubmitted application and provided November 13, 2021 as the target Prescription Drug User Fee Act (PDUFA) action date.
U.S. FDA Accepts PharmaEssentia’s BLA Resubmissi... - MPN Voice
U.S. FDA Accepts PharmaEssentia’s BLA Resubmission for Besremi
Written by
Manouche
To view profiles and participate in discussions please or .
2 Replies
•
That's good news. Perhaps we will then have it available in the Uk. Thanks for posting information.
Thanks for the update Manouche.
Not what you're looking for?
You may also like...
Dr Verstovsek on Besremi and Outcomes
targetedonc.com/view/first-fda-approved-interferon-improves-outcomes-in-polycythemia-vera
What is your Besremi Dose?
are not at this level.
This figure is from the FDA's detailed analysis for approval of Bes which...
Ruxolitinib filed to FDA for PV
I noticed that ruxolitinib has been filed to the FDA for treatment for PV. Looks like they will...
Rusfertide (for HCT Control)- FDA status
said it plans to seek FDA approval for rusfertide for treating polycythemia vera in late 2025\\"...
FDA Rejects Ropeginterferon alfa-2b for Polycythemia Vera
https://patientworthy.com/2021/03/22/fda-rejects-ropeginterferon-alfa-2b-polycythemia-vera/
Besremi, Pegasys and Jakafi adverse event question?
Besremi decision time
