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). ...

Read more →

Landmark listing of first three countries as WHO listed regulatory authorities

31 October 2023 - The Health Sciences Authority, Singapore; the Ministry of Food and Drug Safety, Republic of Korea; and ...

Read more →

Switzerland restricts reimbursement of orphan drugs

30 October 2023 - New rules for the reimbursement of orphan drugs and other unlisted medicines will become effective in Switzerland ...

Read more →

Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.

21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk ...

Read more →

Swiss drug review times trail FDA and EMA, increased due to COVID

21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...

Read more →

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 ...

Read more →

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 ...

Read more →

Pricing of medicines in Switzerland | Three yearly price review: What are the most important changes for 2023?

24 January 2023 - The Federal Office of Public Health reviews the price of every medicinal product that is reimbursed under ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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) ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →