PharmaEssentia Provides U.S. Regulatory Update on Ropeginterferon alfa-2b-njft for the Treatment of Polycythemia Vera (PV)

[Manouche]

« PharmaEssentia Corporation a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s Biologics License Application (BLA) for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera (PV), a rare blood cancer. »

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[Manouche]

« PharmaEssentia Corporation, a biopharmaceutical innovator, has recently received a CRL (complete response letter) from the U.S. FDA for its BLA (Biologics License Application) regarding ropeginterferon alfa-2b-njft, a medication for use in the treatment of PV (polycythemia vera), which is a rare blood cancer. »

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[hunter5582]

Hopefully the FDA will be able to complete the process ASAP. It is unfortunate that the COVD travel restrictions are slowing things down, but not a big surprise. '

Hope we all get good news soon.