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Neurocrine Biosciences Announces U S FDA Accepts New Drug Application for INGREZZA® (valbenazine) Oral Granules Sprinkle Formulation

/PRNewswire/ Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application.

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Takeda and HUTCHMED Announce New Drug Application NDA for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

Takeda TSE4502NYSETAK and HUTCHMED China Limited NasdaqAIMHCM HKEX13 HUTCHMED today announced that the U.S. Food and Drug Administration FDA has granted priority review of the New Drug Application NDA for fruquintinib a highly selective and potent inhibitor of vascular endothelial growth factor receptors VEGFR 1 2 and 3 for the treatment of adult patients with previously treated metastatic colorectal cancer CRC.

United kingdomHong kongUnited statesAl qahirahJun saitoMark leeSara noonanMichael shiAhcene djaballahJemma nashZhou yiBen atwell alex shawGastroenterol hepatolAnnie chengAwny farajallahExchange commission

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review
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United statesHong kongAl qahirahUnited kingdomJemma nashPanmure gordonMichael shiMark leeBen atwell alex shawZhou yiAwny farajallahJun saitoAnnie chengAhcene djaballahGastroenterol hepatolSara noonan

Takeda Pharmaceutical Company Limited: Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 30, 2023 NDA Includes Results From the Phase 3 FRESCO-2 and FRESCO Clinical Trials Takeda (TSE:4502/NYSE:TAK) and HUTCHMED

United kingdomAl qahirahUnited statesHong kongAnnie chengMichael shiJemma nashAsia zhou yiPanmure gordonJun saitoGewinn nurAwny farajallahMark leeGastroenterol hepatolAhcene djaballahSara noonan

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

− Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 30, 2023

United kingdomHong kongUnited statesAl qahirahAnnie chengMichael shiMark leeSara noonanJun saitoAwny farajallahAhcene djaballahJemma nashGastroenterol hepatolBen atwell alex shawZhou yiInternational agency for research on cancer