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 ...
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.
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 ...
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 In draft guidance, the National Institute for Health and Care ...
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. On November 22 nd, the Food and Drug Administration (FDA) approved ...
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) ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min Hemgenix will have a list price ...
- 4- and 5-gram ZEMAIRA® vials may reduce the number of vials necessary for reconstitution, thereby providing convenience and lowering package waste KING OF PRUSSIA, Pa., Jan. 2, 2024 /PRNewswire/ -- ...
MELBOURNE, Australia & ST. GALLEN, Switzerland--(BUSINESS WIRE)--Regulatory News: AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR CSL Behring AG, Berne, Switzerland, a wholly-owned subsidiary of global ...
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