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FDA Grants Fast Track Designation to Prevail’s PR001 for the Treatment of Parkinson’s Disease with a GBA1 Mutation

NEW YORK, July 08, 2019 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. (Nasdaq: PRVL) (Prevail), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the Company’s lead gene therapy program, …

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FDA Approves Grifols’ Xembify, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies

Barcelona, July 4, 2019.– Grifols (MCE:GRF, MCE:GRF.P NASDAQ:GRFS), a leading global producer of plasma-derived medicines, announced today that Xembify®, its new 20% subcutaneous immunoglobulin, has been approved by the U.S. Food and Drug Administration (FDA). Xembify® is used to treat primary immunodeficiencies. The FDA approval marks the culmination of an important …

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FDA Declines to Approve Daiichi Sankyo’s Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

Tokyo and Basking Ridge, NJ – (June 21, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of quizartinib for the treatment of adults with relapsed/ refractory FLT3-ITD acute …

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FDA Approves Allergan’s Botox for Treatment of Pediatric Patients with Upper Limb Spasticity

DUBLIN, June 21, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company’s supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX® was granted a six-month Priority Review by the FDA, which is typically granted …

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FDA Accepts sBLA for Ultomiris Under Priority Review for the Treatment of Atypical Hemolytic Uremic Syndrome

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, for the treatment of people with atypical hemolytic uremic syndrome (aHUS) in order to inhibit complement-mediated …

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FDA Approves Merck’s Keytruda as Monotherapy for Patients with Metastatic Small Cell Lung Cancer with Disease Progression on or After Platinum-Based Chemotherapy

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based …

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Abeona Therapeutics Receives FDA Fast Track Designation for ABO-202 AAV9 Gene Therapy in CLN1 Disease

NEW YORK and CLEVELAND, June 18, 2019 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its ABO-202 program. ABO-202, the Company’s novel one-time AAV9 gene therapy …

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FDA Grants Fast Track Designation to Torque’s First Deep-Primed T Cell Cancer Immunotherapy Program, TRQ-1501

CAMBRIDGE, Mass., June 18, 2019 /PRNewswire/ — Torque, a clinical-stage immuno-oncology company developing Deep-Primed™ T Cell Therapeutics to direct immune power deep within the tumor microenvironment, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Torque’s first Deep-Primed™ T cell immunotherapy program, TRQ-1501 (Deep …

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FDA Approves Novo Nordisk’s Victoza for Treatment of Type 2 Diabetes in Patients Aged 10-17 Years

PLAINSBORO, N.J., June 17, 2019 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza® (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes. As the first glucagon-like peptide-1 (GLP-1) receptor …

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Eiger’s Avexitide Granted Breakthrough Therapy Designation by FDA for the Treatment of Post-Bariatric Hypoglycemia

PALO ALTO, Calif., June 17, 2019 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycemia (PBH).  …

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