Blog
RSS FeedPosted by Michael Wonder on 28 Dec 2023
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). ...
Posted by Michael Wonder on 12 Dec 2023
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 ...
Posted by Michael Wonder on 03 Oct 2023
Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5
28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...
Posted by Michael Wonder on 21 Jun 2023
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 ...
Posted by Michael Wonder on 09 Mar 2023
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. ...
Posted by Michael Wonder on 06 Dec 2022
Swissmedic approves Quviviq (daridorexant) – a first in class treatment for chronic insomnia disorder to improve both nighttime symptoms and daytime functioning
5 December 2022 - Quviviq, Switzerland's first approved dual orexin receptor antagonist, offers a new targeted mechanism of action that decreases ...
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 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 30 Aug 2022
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 ...
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 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 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 25 Apr 2022
Swissmedic grants conditional marketing authorisation for Novavax COVID-19 vaccine
13 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine authorised for use in Switzerland. ...