Octapharma receives Swissmedic approval for fibryga to treat congenital and acquired fibrinogen deficiencies

26 November 2018 - Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorisation to its new ...

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Novartis leukaemia drug approved in Switzerland

22 October 2018 - Basel-based pharmaceutical company Novartis has received approval for its personalised cell therapy Kymriah in Switzerland. Children ...

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Swissmedic approves Ameluz in combination with daylight photodynamic therapy in Switzerland

1 October 2018 - Biofrontera announced today that Swissmedic, the Swiss national approval and supervisory authority for drugs and medical ...

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Dutch, Swiss regulators forge agreement on data exchange

14 September 2018 - The heads of the Netherland’s Medicines Evaluation Board and Swissmedic have signed a memorandum of understanding ...

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'The Swiss government must make lifesaving drugs affordable'

22 May 2018 - Swiss health NGO Public Eye has launched a campaign calling for Swiss authorities to combat the ...

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A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA

19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA ...

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Swissmedic validates Shire’s marketing authorisation application for investigational hereditary angioedema treatment lanadelumab

18 April 2018 - Swissmedic validation shows continued regulatory progress for lanadelumab. ...

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Roche's Alecensa approved in Switzerland

3 April 2018 - Roche said Tuesday that its prescription medicine Alecensa has been approved in Switzerland as a first-line ...

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FDA approves drugs before EMA and Swissmedic, comparison finds

23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...

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Swissmedic accepts our filing for edaravone to treat ALS

23 January 2018 - Mitsubishi Tanabe Pharma Corporation announced today that the Swissmedic has accepted its filing for edaravone, an intravenous ...

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Swissmedic updates biosimilar guidance to allow comparators of US origin

11 January 2018 - The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in ...

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Veltassa approved for marketing in Switzerland for the treatment of hyperkalaemia

3 January 2018 - SwissMedic has approved patiromer to be marketed in Switzerland as Veltassa for the treatment of hyoperkalaemia ...

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Ferring receives Swiss approval for Rekovelle, the first personalised fertility treatment using an approved dosing algorithm

27 November 2017 - Approval is based on a comprehensive clinical development programme (ESTHER), involving patients in 11 countries and over ...

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Swissmedic updates requirements concerning the fast-track authorisation procedure

16 October 2017 - On 1 October 2017, the Swiss Agency for therapeutic products updated its guidance document concerning the ...

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Roche’s Ocrevus (ocrelizumab) approved in Switzerland for primary progressive and relapsing forms of multiple sclerosis

28 September 2017 - Authorisation in Switzerland marks the first for Ocrevus in Europe following approvals in North America, South America, ...

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