Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)

1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...

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Swiss National Council votes to accept FDA approved medical devices

29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...

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Moderna applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine

18 November 2022 - Application submitted for Spikevax Bivalent Original / Omicron BA.4-5 (mRNA-1273.222) ...

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Swiss drugs regulator approves one of Pfizer's COVID-19 booster shots

10 October 2022 - Swiss drugs regulator Swissmedic said on Monday it had temporarily approved Pfizer's COVID-19 booster shot targeting ...

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Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine

22 September 2022 - Pfizer said on Thursday it had submitted an application to Swissmedic for authorisation of a further ...

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Swiss regulator gives green light to first drug to prevent Covid-19

16 September 2022 - Swissmedic has issued a temporary marketing authorisation for AstraZeneca’s drug Evusheld, making it the first Covid-19 prophylaxis ...

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Swissmedic authorizes Novavax Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 and as a booster in adults aged 18 and older

5 September 2022 - Novavax, today announced that Swissmedic has expanded its temporary authorisation of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in Switzerland ...

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Swissmedic authorises Novavax Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 and as a booster in adults aged 18 and older

2 September 2022 - Novavax today announced that Swissmedic has expanded its temporary authorisation of Nuvaxovid COVID-19 vaccine in Switzerland for ...

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Swissmedic authorises Moderna's Omicron targeting bivalent booster candidate MRNA-1273.214

29 August 2022 - Switzerland becomes among the first countries in the world to approve the use of a next-generation ...

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Kapruvia approved in Switzerland with additional regulatory decisions expected in H2, 2022

19 August 2022 - Regulatory decisions in Australia and Singapore expected by the end of 2022. ...

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Novavax files in Switzerland for expanded conditional marketing authorisation of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 and as a booster in individuals aged 18 and over

7 July 2022 - Novavax today announced the submission of a request to Swissmedic to expand the conditional marketing authorisation ...

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BioCryst announces approval of Orladeyo (berotralstat) by Swissmedic

7 June 2022 -  -- BioCryst Pharmaceuticals today announced that Swissmedic has granted marketing authorisation for oral, once-daily Orladeyo (berotralstat) ...

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Swiss drug prices still soar above European levels

31 May 2022 - Compared with nine other European countries, Switzerland remains a high-price island for medicines, according to an annual ...

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Hansa Biopharma announces temporary marketing authorisation in Switzerland for Idefirix (imlifidase) in kidney transplantation

13 May 2022 - Idefirix is now granted marketing authorisation within the EU, the U.K., Israel and Switzerland. ...

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Swissmedic has accepted the new oral edarvarone formulation for the treatment of ALS

25 April 2022 - Mitsubishi Tanabe Pharma announced that Swissmedic has accepted the filing for an investigational oral suspension formalation ...

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