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FDA Grants Priority Review and Breakthrough Therapy Designation for Zelboraf in Erdheim-Chester Disease with BRAF V600 Mutation

17:05 EDT 7 Aug 2017 | Speciality Pharma Journal

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Zelboraf® (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood …

Original Article: FDA Grants Priority Review and Breakthrough Therapy Designation for Zelboraf in Erdheim-Chester Disease with BRAF V600 Mutation

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