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AstraZeneca’s Lynparza Granted FDA Priority Review for Maintenance Setting in Ovarian Cancer Patients

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for LYNPARZA™ (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. The FDA has also granted priority review status with a …

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FDA Approves Genentech’s Ocrevus for Relapsing and Primary Progressive Forms of Multiple Sclerosis

South San Francisco, CA — March 28, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The …

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Tesaro’s PARP Inhibitor Zejula Wins FDA Approval for Treatment of Ovarian Cancer

WALTHAM, MA, March 27, 2017 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULA™ (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary …

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Ziopharm Announces Successful End-of-Phase 2 Meeting with FDA for its Gene Therapy in Recurrent Glioblastoma

BOSTON, March 27, 2017 (GLOBE NEWSWIRE) — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, today announced the receipt of positive guidance from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its lead gene therapy product candidate, Ad-RTS-hIL-12 plus orally administered veledimex …

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Akashi Announces FDA Gives Okay to Resume Clinical Development of its DMD Drug

CAMBRIDGE, Mass., March 22, 2017 – Akashi Therapeutics, Inc. a clinical stage biopharmaceutical company developing treatments for patients with Duchenne muscular dystrophy (DMD), today reported that the U.S. Food and Drug Administration (FDA) has completed its review and concluded that Akashi may resume clinical development of HT-100 (delayed-release halofuginone) in …

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FDA Grants Breakthrough Therapy Designation to Genentech’s Rituxan for Treatment of Pemphigus Vulgaris

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Rituxan® (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of …

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FDA Grants Accelerated Approval to Bavencio, the First Treatment for Rare Form of Skin Cancer

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, …

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Shire’s Hereditary Thrombotic Thrombocytopenic Purpura Treatment Receives Fast Track Status from the FDA

Lexington, Mass. – March 22, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for recombinant ADAMTS13 (SHP655 – historically known as BAX930) for treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in …

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FDA Approves Newron’s Xadago for Treatment of Patients with Parkinson’s Disease

Milan, Italy and Morristown, NJ, U.S.A., – March 21, 2017 – Newron Pharmaceuticals S.p.A. (“Newron”, SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, and its partners Zambon S.p.A. and US WorldMeds, LLC, announced today …

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FDA Grants Tentative Approval to Mylan’s HIV Drug Combo Under PEPFAR

HERTFORDSHIRE, England and PITTSBURGH, March 20, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Efavirenz, Lamivudine and …

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