The sBLA is supported by data from the phase 3 SURPASS-ET trial, as well as confirmatory data from the phase 2b EXCEED-ET trial.
The FDA has accepted the supplemental Biologics License Application (BLA) for ropeginterferon alfa-2b-njft (Besremi), a ...
The FDA accepted Besremi's application for essential thrombocythemia, supported by SURPASS-ET and EXCEED-ET trial results, with a review target date of August 30, 2026. Essential thrombocythemia is a ...
Taiwan-based PharmaEssentia Corporation, a biopharma seeking to deliver new biologics in hematology and oncology, has announced that the US Food and Drug Administration (FDA) has accepted the ...
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles ...
BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep ...
Nearly all (90%) of essential thrombocythemia (ET) patients treated with INCA033989 at the higher dose achieved a hematologic response (HR) with 83.3% achieving a complete HR Molecular responses were ...
Start of the phase 1b trial in a new indication expands Step Pharma’s clinical programme, building on the development of dencatistat in lymphoma and solid tumours This milestone marks the third ...
Hemorrhagic events post-diagnosis in patients with ET significantly increase mortality risk, more than thrombosis or disease progression. Intracranial hemorrhage is the most lethal bleeding ...
BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep ...
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