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FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat to Prevent Hereditary Angioedema Attacks

10:52 EST 18 Feb 2020 | Speciality Pharma Journal

RESEARCH TRIANGLE PARK, N.C., Feb. 18, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has accepted and filed its new drug application (NDA) for the approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks. The Prescription Drug User Fee Act (PDUFA) …

Original Article: FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat to Prevent Hereditary Angioedema Attacks

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