Blog
RSS FeedPosted 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 30 Nov 2022
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 ...
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 11 Oct 2022
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 ...
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 17 Sep 2022
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 ...
Posted by Michael Wonder on 06 Sep 2022
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 ...
Posted by Michael Wonder on 03 Sep 2022
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 ...
Posted by Michael Wonder on 20 Aug 2022
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. ...
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 Jun 2022
US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...
Posted by Michael Wonder on 08 Jun 2022
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) ...
Posted by Michael Wonder on 31 May 2022
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 ...
Posted by Michael Wonder on 14 May 2022
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. ...
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 ...