KalVista Pharmaceuticals announces European Commission and Swissmedic approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema

19 September 2025 - First European launch of Ekterly expected in Germany Q4, 2025. ...

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Idorsia’s Jeraygo (aprocitentan) approved in Switzerland for the treatment of resistant hypertension

19 September 2025 - Jeraygo is a new oral antihypertensive therapy – the first systemic hypertension treatment to target a new ...

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Swissmedic approves Ifinwil (eflornithine) for children diagnosed with high-risk neuroblastoma

8 July 2025 - Norgine is pleased to announce that Swissmedic has approved the registration of Ifinwil (eflornithine) as monotherapy ...

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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 ...

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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 ...

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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 ...

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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 ...

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Swissmedic authorises dengue fever vaccine

2 August 2024 - To date, no vaccine against dengue fever was authorised in Switzerland.  ...

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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). ...

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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 ...

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Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5

28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...

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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 ...

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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. ...

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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 ...

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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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