Blog
RSS FeedPosted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 27 Feb 2025
Swissmedic approves CSL Behring’s Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema
26 February 2025 - The approval marks the fifth regulatory approval of Andembry, reinforcing CSL’s decades long commitment to delivering ...
Posted by Michael Wonder on 19 Feb 2025
Galderma’s Nemluvio (nemolizumab) granted marketing authorisation in the United Kingdom and Switzerland for moderate to severe atopic dermatitis and prurigo nodularis
18 February 2025 - These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review ...
Posted by Michael Wonder on 01 Feb 2025
Refined interpretation of the Mutual Recognition Agreement between Canada and Switzerland
31 January 2025 - Swissmedic and Health Canada agreed to expand their approach regarding the implementation of the current mutual ...
Posted by Michael Wonder on 15 Nov 2024
Leo Pharma’s Anzupgo (delgocitinib) cream achieves marketing approval in Switzerland
14 November 2024 - In addition to the results of the DELTA 1,2 and 3 trials, the marketing approval is supported ...
Posted by Michael Wonder on 18 Oct 2024
CSL Vifor and Travere Therapeutics announce SwissMedic approval of Filspari (sparsentan) for the treatment of IgA nephropathy
17 October 2024 - Temporary marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
Posted by Michael Wonder on 04 Oct 2024
Medicines regulators weigh hope and hype with new Alzheimer’s drugs
30 September 2024 - Swiss medicines regulator Swissmedic is expected to decide by the end of the year whether to approve ...
Posted by Michael Wonder on 25 Sep 2024
Santhera announces acceptance by Swissmedic of marketing authorisation application for Agamree (vamorolone) in Duchenne muscular dystrophy
24 September 2024 - Santhera Pharmaceuticals announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the ...
Posted by Michael Wonder on 03 Aug 2024
Swissmedic authorises dengue fever vaccine
2 August 2024 - To date, no vaccine against dengue fever was authorised in Switzerland. ...
Posted by Michael Wonder on 25 Jul 2024
Switzerland’s drug approval process lags behind Europe
24 July 2024 - According to a recent study, medicines are approved on average 249 days later in Switzerland than by ...
Posted by Michael Wonder on 02 Jul 2024
Standardisation of practice on publication of indications in Swiss Public Assessment Report
1 July 2024 - In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in ...
Posted by Michael Wonder on 03 Jun 2024
Project Orbis: quicker access to promising cancer treatments
29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...
Posted 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
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). ...