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 ...

KING OF PRUSSIA, Pa., Aug. 3, 2021 /PRNewswire/ -- CSL Behring, a global biotherapeutics leader received U.S. Food and Drug Administration (FDA) approval for its supplemental request (submitted Aug.

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 ...

HEMGENIX ® is the first and only gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B and to show sustained efficacy and safety at three years ...

Exclusive licensing grants Lilly development and commercialization rights for clazakizumab beyond ESKD-related cardiovascular prevention, while CSL retains the ESKD cardiovascular events indication.

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 In draft guidance, the National Institute for Health and Care ...

- Hizentra ® is the #1 immune globulin prescribed for Primary Immunodeficiency (PI) in the U.S. - Hizentra is the first and only subcutaneous immune globulin (SCIg) treatment approved for Chronic ...

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.

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) ...

KING OF PRUSSIA, Pa., May 16, 2021 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced the results of a new meta-analysis of seven interventional Phase 3 clinical trials that ...

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 ...