The FDA has approved the first hemophilia B gene therapy, a one-time treatment that addresses a root cause of this inherited disorder and potentially eliminates the need for regular infusions that ...

CSL Behring has made a name for itself manufacturing biologics and plasma, but its unveiling of a new R&D site—slated to be the company’s largest—is evidence of expanded development efforts. The new ...

The FDA has accepted CSL Behring’s priority review application for a hemophilia B gene therapy, potentially fast-tracking the drug after a bumpy ride that included a clinical hold—and later, a lift.

94 percent of patients eliminated factor IX prophylaxis and remained free of continuous prophylaxis through four years post-treatment Mean factor IX activity levels were sustained at near normal ...

The Pennsylvania biotech company CSL Behring says it is on track to file for approval of its hemophilia B gene therapy by the end of June after releasing pivotal data showing statistical superiority ...

– Etranacogene dezaparvovec (AMT-061) is an investigational gene therapy that may potentially provide people with hemophilia B with years of functional levels of Factor IX, a blood-clotting protein ...

In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million international units (IUs) ...

The U.K.’s cost-effectiveness watchdog has tossed cold water on CSL Behring and uniQure’s pricey new hemophilia B gene therapy Hemgenix. In draft guidance, the National Institute for Health and Care ...

KING OF PRUSSIA, Pa., May 6, 2021 /PRNewswire/ — Global biotherapeutics leader CSL Behring today announced the closing of its global Commercialization and License agreement with uniQure (NASDAQ: QURE) ...