Keyword: Food and Drug Administration (FDA)

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FDA Approves US Merck-Pfizer Cancer Treatment

30.04.2019 - Two months earlier than expected, the US Food and Drug Administration (FDA) has greenlighted the use of Merck & Co’s multi-indication cancer treatment Keytruda in combination with...

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EMA Opens in Amsterdam

14.03.2019 - The European Medicines Agency (EMA) has started operating from new premises in Amsterdam, the Netherlands, as of Mar. 11, after leaving its previous base in London in preparation...

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FDA Chief Scott Gottlieb Resigns

07.03.2019 - Scott Gottlieb has announced plans to step down as head of the US Food and Drug Administration (FDA) after two years in the position. The 46-year-old physician was one of the few...

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FDA Struggles with US Government Shutdown

18.01.2019 - The US Food and Drug Administration (FDA) is recalling furloughed employees to carry out inspections as the longest-ever US government shutdown moves toward its fifth week...

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FDA Chief Criticizes US Insulin Pricing

18.12.2018 - Scott Gottlieb, Commissioner of the US Food and Drug Administration is focusing on insulin drugs in the current round of the government’s efforts to lower pharmaceutical prices...

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FDA Greenlights Bayer-Loxo’s Vitrakvi

05.12.2018 - A new type of cancer treatment developed by a partnership of Bayer with biotech partner Loxo Oncology has won approval from the US Food and Drug Administration (FDA). Vitrakvi is...

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FDA to Overhaul Medical Device Approval

28.11.2018 - In an effort to move technology forward, the US Food and Drug Administration (FDA) is overhauling the approval procedure for new medical devices. Since 1976, device manufacturers...

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FDA Approves Dompé’s Rare Eye Disease Drug

29.08.2018 - US regulators have approved the first drug to treat neurotrophic keratitis, a rare degenerative disease that progressively affects the cornea, the clear layer at the front of the...