FDA News

Janssen Seeks FDA Approval for Expanded Use of its Multiple Myeloma Drug

RARITAN, N.J., Aug. 17, 2016 /PRNewswire/ — Janssen Biotech, Inc. announced today a supplemental Biologics License Application (sBLA) for daratumumab (DARZALEX®) has been submitted to the U.S. Food and Drug Administration (FDA). The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and …

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FDA Grants Orphan Drug Designation to Tivorsan Pharmaceuticals’ Duchenne Muscular Dystrophy Drug

PROVIDENCE, R.I.–(BUSINESS WIRE)–Tivorsan Pharmaceuticals, Inc., a biotechnology company that is pioneering a novel approach to treating all forms of Duchenne Muscular Dystrophy (DMD) and other serious, debilitating neuromuscular disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead investigational drug, human …

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FDA Approves Heron’s Sustol Extended-Release Injection for the Prevention of CINV

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ:HRTX), today announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with …

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Merck’s Keytruda Wins FDA Approval for Treatment of Patients with Head and Neck Cancer

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® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with …

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FDA Issues Draft Updated Recommendations on Submitting a New 510(k) for Device Modifications

The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices. “These draft recommendations are intended to help manufacturers …

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FDA Puts a Partial Clinical Hold on Adaptimmune’s Cancer Therapy Trial

PHILADELPHIA and OXFORD, United Kingdom, Aug. 03, 2016 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy for treatment of cancer, today announced that it has received notice from the U.S. Food and Drug administration that a partial clinical hold has been placed on its planned pivotal …

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Novartis’ Investigational Breast Cancer Drug Receives FDA Breakthrough Therapy Designation

Basel, August 3, 2016 – Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. LEE011 is a selective …

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MEI Pharma’s Pracinostat Receives Breakthrough Therapy Designation from the FDA

SAN DIEGO, Aug. 1, 2016 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with azacitidine for …

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FDA Grants Fast Track Status to Shire’s Treatment for Patients who have NASH with Liver Fibrosis

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of …

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Sanofi’s Adlyxin Receives FDA Approval for Treatment of Type 2 Diabetes

PARIS, July 27, 2016 /PRNewswire/ — Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin™ (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. “The approval of Adlyxin reaffirms our …

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