Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.

21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk ...

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MorphoSys and Incyte announce Swissmedic temporary approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with r/r DLBCL

22 March 2022 - Minjuvi is a new therapeutic option for eligible DLBCL patients in Switzerland addressing an urgent unmet medical ...

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BeiGene announces approval for Brukinsa (zanubrutinib) by Swissmedic for treatment of adult patients with Waldenström’s macroglobulinaemia

17 February 2022 - With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global ...

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Deciphera announces approval of Qinlock in Switzerland for the treatment of fourth-line gastro-intestinal stromal tumour

12 October 2021 - Seventh approval worldwide for Qinlock and first European approval. ...

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Clovis Oncology announces availability of and reimbursement for Rubraca (rucaparib) tablets for women with relapsed ovarian cancer in Switzerland

24 August 2021 - Rubraca is commercially available in Germany, United Kingdom, Italy, Spain, France, Netherlands, United States of America and ...

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BeiGene announces acceptance by Swissmedic of marketing authorisation application for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia

18 August 2021 - BeiGene announced that Swissmedic has accepted the marketing authorisation application for Brukinsa, a treatment option for adult ...

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PharmaMar has filed lurbinectedin for Temporary Marketing Authorisation with the Swiss Agency for Therapeutic Products

20 July 2020 - The filing is based on the Phase II multi-centre basket trial efficacy data. ...

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FDA’s Project Orbis may expand to Singapore and Switzerland

12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...

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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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EU green light for Lilly's lung cancer drug Portrazza

24 February 2016 - European regulators have approved Eli Lilly’s Portrazza as a treatment for patients with advanced non-small cell lung ...

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Novartis receives EU approval for Farydak, the first in its class of anticancer agents approved for patients with multiple myeloma

4 September 2015 - Novartis announced today that the European Commission has approved Farydak (panobinostat, previously known as LBH589) capsules, in ...

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Novartis receives EU approval for Tafinlar and Mekinist, first combination approved for patients with aggressive form of melanoma

1 September 2015 - Novartis today announced that the European Commission has approved the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) ...

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