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The FDA approved a new generic valsartan to control blood pressure. It was a mean to solve the problem of reduced supplies after some pharmaceutical manufacturers recalled their valsartan drugs because of the potential risk of cancer. The FDA is reviewing the marketing application for the generic valsartan manufactured by Indian company Elkem Laboratories Ltd,…
The European Medicines Agency (EMA) accepted for consideration a authorization application from Merck KGaA for Bavencio (avelumab) for the treatment of patients with advanced renal cell carcinoma (CRP). The regulator is considering the application for the use of Bavencio in combination with Inlyta (axitinib), which was submitted on the results of Phase III pivotal clinical…
Roche’s immunotherapy drug Tecentriq was approved in the United States for treatment of patients suffering from triple negative breast cancer (TNBC), which is a progress in fight with this aggressive disease. The FDA approved Tecentriq in combination with a chemotherapeutic drug Abraxane for the treatment of inoperable locally advanced or metastatic TNMP in patients with…
The industry’s pledge to improving the patient experience drove significant change in 2018 and will continue to do so this year, with so-called “convenience” services to become standard, says Greenphire CCO, who outlines several other trends to watch. The clinical trial sector’s overall commitment to improving the patient experience was perhaps the most significant positive…
Sanofi received a Marketing Authorization from US regulatory authorities for caplacizumab (caplacizumab) for the treatment of thrombotic thrombocytopenic purpura. This is quite a serious and rare disease. Such therapy is registered only for adult patients. This decision was made after studying the results of a clinical study that was conducted with 145 patients. Clinical trial…
The Federal State Unitary Enterprise “State Scientific Research Institute of Highly Pure Biopreparations” FMBA decided to return to the market the original drug Rexod® (INN: superoxide dismutase), which was developed and produced by the Institute. The drug is available in a new dosage form – solution for injection. Superoxide dismutase is an endogenous acceptor of…