Curium announces submission of the marketing authorisation application for Pylclari, an innovative (18F)-PSMA PET tracer indicated in adults with prostate cancer to Swissmedic

22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...

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Swissmedic approves Beyfortus for RSV prophylaxis in newborns, infants and young children

28 December 2023 - Following a thorough review, Swissmedic has authorised the medicinal product Beyfortus from marketing authorisation holder Sanofi-Aventis (Suisse). ...

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Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn

18 December 2023 - The manufacturer Novavax is no longer pursuing marketing authorisation for its COVID-19 vaccine in Switzerland. ...

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Orchard Therapeutics receives Swissmedic approval for Libmeldy in early-onset MLD

11 December 2023 - Orchard Therapeutics today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy (atidarsagene autotemcel), a ...

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Landmark listing of first three countries as WHO listed regulatory authorities

31 October 2023 - The Health Sciences Authority, Singapore; the Ministry of Food and Drug Safety, Republic of Korea; and ...

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Switzerland restricts reimbursement of orphan drugs

30 October 2023 - New rules for the reimbursement of orphan drugs and other unlisted medicines will become effective in Switzerland ...

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Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5

28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...

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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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Swiss drug review times trail FDA and EMA, increased due to COVID

21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...

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Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5

13 July  2023 - Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5 ...

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Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345

5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...

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Akebia announces Swissmedic approval of Vafseo (vadadustat)

20 June 2023 - Akebia Therapeutics today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorisation ...

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Aurinia Pharmaceuticals announces Swissmedic approval of Lupkynis (voclosporin)

2 May 2023 - Aurinia Pharmaceuticals today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization of ...

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Swissmedic issues unlimited authorisation for booster dose of Moderna's bivalent COVID-19 Original/Omicron BA.4-5 vaccine

8 March 2023 - Spikevax bivalent Original/Omicron BA.4-5 mRNA vaccine authorised for people aged 18 and over. ...

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Pricing of medicines in Switzerland | Three yearly price review: What are the most important changes for 2023?

24 January 2023 - The Federal Office of Public Health reviews the price of every medicinal product that is reimbursed under ...

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