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RSS FeedPosted by Michael Wonder on 23 Feb 2024
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 ...
Posted by Michael Wonder on 28 Dec 2023
Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn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. ...
Posted by Michael Wonder on 17 Jul 2023
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 ...
Posted by Michael Wonder on 04 May 2023
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 ...
Posted by Michael Wonder on 03 Dec 2022
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 ...
Posted by Michael Wonder on 21 Nov 2022
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) ...
Posted by Michael Wonder on 23 Sep 2022
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 ...
Posted by Michael Wonder on 10 Jul 2022
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 ...
Posted by Michael Wonder on 26 Apr 2022
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 ...
Posted by Michael Wonder on 14 Feb 2022
Novavax files for conditional marketing authorisation of COVID-19 Vaccine in Switzerland
14 February 2022 - Novavax today announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorisation ...
Posted by Michael Wonder on 27 Aug 2021
BioCryst announces acceptance of regulatory applications for Orladeyo (berotralstat) by Health Canada and Swissmedic
25 August 2021 - BioCryst Pharmaceuticals today announced that the new drug submission for Orladeyo (berotralstat) has been accepted for ...
Posted by Michael Wonder on 19 Aug 2021
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 ...
Posted by Michael Wonder on 16 Jun 2021
Emmaus Life Sciences announces submission of marketing authorisation application to Swissmedic; Ideogen to manage early access program
15 June 2021 - Emmaus Life Sciences anounced today it has received confirmation from the Swiss Agency for Therapeutic Products ...
Posted by Michael Wonder on 15 Jun 2021
Moderna seeks vaccine approval for adolescents
11 June 2021 - US-based biotech company Moderna is applying for the use of its COVID-19 vaccine for adolescents aged 12 ...
Posted by Michael Wonder on 21 Apr 2021
Switzerland ‘unfortunately’ still awaiting AstraZeneca COVID-19 vaccine data
21 April 2021 - Switzerland’s drug regulator is still awaiting data needed to consider whether to approve AstraZeneca’s COVID-19 vaccine, ...