« 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. »
PharmaEssentia Provides U.S. Regulatory Update o... - MPN Voice
PharmaEssentia Provides U.S. Regulatory Update on Ropeginterferon alfa-2b-njft for the Treatment of Polycythemia Vera (PV)
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Manouche
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« 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. »
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.
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