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FDA Grants Priority Review to AstraZeneca and Merck’s Lynparza in Metastatic Breast Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of LYNPARZA® (olaparib) tablets in patients with germline BRCA-mutated …

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FDA Grants Priority Review for AstraZeneca’s sBLA for Imfinzi in Advanced Non-Small Cell Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not …

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FDA Committee Unanimously Recommends Approval of Spark’s Gene Therapy for Rare Eye Disease

PHILADELPHIA, Oct. 12, 2017 (GLOBE NEWSWIRE) — Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee has unanimously recommended (16-0) approval of LUXTURNA™ (voretigene neparvovec), an investigational, potential one-time gene therapy, …

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FDA Accepts Prometic’s BLA for its Rare Disease Drug Ryplazim

LAVAL, QC, Oct. 13, 2017 /PRNewswire/ – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced that the U.S Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its plasminogen replacement therapy (RyplazimTM) having  granted a priority review status and set a Prescription Drug …

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FDA Grants Priority Review for Lilly’s Verzenio as Initial Treatment of Advanced Breast Cancer

INDIANAPOLIS, Oct. 12, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its New Drug Application (NDA) for Verzenio™(abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA was based upon the positive interim results from MONARCH 3, a study …

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FDA Grants Fast Track Designation to Astellas’ Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia

TOKYO, Oct. 10, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia …

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Clovis Oncology Submits sNDA for Rucaparib as Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology (NASDAQ: CLVS) announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for rucaparib as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or …

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FDA Grants Breakthrough Therapy Designation to AstraZeneca’s Tagrisso for EGFR Mutated NSCLC

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at …

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FDA Approves Test for Screening Zika Virus in Blood Donations

The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood …

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FDA Grants Orphan Drug Designation to Kadmon’s Chronic Graft-Versus-Host Disease Treatment

NEW YORK–(BUSINESS WIRE)–Kadmon Holdings, Inc. (NYSE: KDMN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to KD025, the Company’s Rho-associated coiled-coil kinase (ROCK) inhibitor, for the treatment of chronic graft-versus-host disease (cGVHD), a serious complication following allogeneic bone marrow or stem cell transplantation. KD025 …

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