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Advances

FDA approves 2 injectable diabetes drugsTwo new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.
Ixazomib for multiple myelomaFDA approved ixazomib (Ninlaro, Takeda) in combination with lenalidomide and dexamethasone
FDA approves Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C infectionFDA approved EpclusaTM (sofosbuvir and velpatasvir, (SOF-VEL) for adults with chronic hepatitis C infection both with compensated cirrhosis or without cirrhosis as well as in combination with ribavirin for hepatitis C with decompensated cirrhosis.
Research looks at melanocyte role in tumor formationWhile melanocytes have strong mechanisms for repair, those in individuals with certain risk factors may carry impaired repair responses. Studies have begun to examine melanocytes in patients at risk for developing melanoma with the hope of developing strategies for preventing deadly tumors.
Daclizumab approved for relapsing forms of multiple sclerosisDaclizumab is the first subcutaneous injectable monoclonal antibody to be approved for the treatment of MS.
First "artificial pancreas" for diabetes approved, plus 2 more FDA actionsFDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.
FDA approves first drug for Duchenne muscular dystrophyEven though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September.
New dosage form for migraine treatmentFDA approved Onzetra Xsail (Avanir Pharmaceuticals Inc.)— a fast-acting, low-dose sumatriptan dry powder formulation for the acute treatment of migraine with or without aura in adults.
New drug approved for chemotherapy nauseaFDA recently approved granisetron (Sustol, Heron Therapeutics) extended-release injection to prevent nausea and vomiting associated with repeat courses of chemotherapy.
Merck value rises after new Keytruda approvalMerck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.

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