FDA News

Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …

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The Medicines Company and Alnylam Announce Agreement with FDA on Phase 3 Program for Inclisiran

PARSIPPANY, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) today announced that The Medicines Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of a New …

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FDA Approves Silvergate’s XATMEP, the Only Ready-to-Use Methotrexate Oral Solution

DENVER, April 26, 2017 /PRNewswire/ — Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved XATMEP (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution. XATMEP is indicated …

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FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments

The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms. “Consumers should …

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FDA Approves Sanofi’s Thymoglobulin for Prevention of Acute Kidney Transplant Rejection

BRIDGEWATER, N.J., April 24, 2017 /PRNewswire/ — Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved Thymoglobulin® [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. Kidney disease is the ninth leading cause …

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FDA Grants Breakthrough Therapy and Regenerative Advanced Therapy Designation to Enzyvant’s RVT-802

BASEL, Switzerland, April 17, 2017 /PRNewswire/ — Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RVT-802, Enzyvant’s investigational tissue-based therapy for the treatment of complete DiGeorge Syndrome (cDGS), Breakthrough Therapy designation as …

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Novartis’ CAR-T Therapy Receives Breakthrough Therapy Designation for Diffuse Large B-Cell Lymphoma

Basel, April 18, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have …

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FDA Grants Accelerated Approval to Genentech’s Tecentriq for Treatment of Advanced Bladder Cancer

South San Francisco, CA — April 17, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who …

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FDA Advisory Committee to Review Puma Biotechnology’s Neratinib for the Extended Adjuvant Treatment of HER2+ Early Stage Breast Cancer

LOS ANGELES, Calif.–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on May 24, 2017. Neratinib is an investigational therapy for the …

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FDA Removes Risk Evaluation and Mitigating Strategy (REMS) Requirements for ESAs

a On April 13, the U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy. Below is the Agency’s announcement regarding this action: Epoetin alfa and darbepoetin alfa are Erythropoiesis-Stimulating …

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