On June 26, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen is expected to become commercially available in the U.S. in the coming weeks.
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"The U.S. approval of the BESREMi Pen is a significant milestone both for our company, as well as the patients we serve," said Samuel Lin, Head of Global Operations, PharmaEssentia. "With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care."
"I’m very excited to see the FDA approval of the BESREMi Pen as a new option for patients," said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. "Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence."
(Press release, PharmaEssentia, JUN 26, 2026, View Source [SID1234668975])