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FDA Grants Breakthrough Therapy Designation to Genentech’s Hemlibra for Patients with Hemophilia A Without Inhibitors

09:26 EDT 17 Apr 2018 | Speciality Pharma Journal

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to HEMLIBRA®(emicizumab-kxwh) for people with hemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the development and review of medicines …

Original Article: FDA Grants Breakthrough Therapy Designation to Genentech’s Hemlibra for Patients with Hemophilia A Without Inhibitors

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