Swiss Government expands powers to force firms to make supplies to fight COVID-19

3 April 2020 - The Swiss government on Friday boosted its powers to order companies to raise production of critical ...

Read more →

FDA’s Project Orbis may expand to Singapore and Switzerland

12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...

Read more →

Swissmedic reviewing licence extension for the SGLT2 inhibitor Invokana (canagliflozin) in fast-track procedure

9 October 2019 - The CREDENCE renal outcomes study, which was stopped early in July 2018 owing to positive efficacy findings, ...

Read more →

Mavenclad (cladribine tablets) approved as the first short-course oral treatment for relapsing remitting multiple sclerosis in Switzerland

25 March 2019 - Approval based on extensive clinical development program capturing more than 10,000 patient years of safety data and ...

Read more →

Octapharma receives Swissmedic approval for fibryga to treat congenital and acquired fibrinogen deficiencies

26 November 2018 - Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorisation to its new ...

Read more →

Novartis leukaemia drug approved in Switzerland

22 October 2018 - Basel-based pharmaceutical company Novartis has received approval for its personalised cell therapy Kymriah in Switzerland. Children ...

Read more →

Swissmedic approves Ameluz in combination with daylight photodynamic therapy in Switzerland

1 October 2018 - Biofrontera announced today that Swissmedic, the Swiss national approval and supervisory authority for drugs and medical ...

Read more →

Dutch, Swiss regulators forge agreement on data exchange

14 September 2018 - The heads of the Netherland’s Medicines Evaluation Board and Swissmedic have signed a memorandum of understanding ...

Read more →

'The Swiss government must make lifesaving drugs affordable'

22 May 2018 - Swiss health NGO Public Eye has launched a campaign calling for Swiss authorities to combat the ...

Read more →

A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA

19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA ...

Read more →

Swissmedic validates Shire’s marketing authorisation application for investigational hereditary angioedema treatment lanadelumab

18 April 2018 - Swissmedic validation shows continued regulatory progress for lanadelumab. ...

Read more →

Roche's Alecensa approved in Switzerland

3 April 2018 - Roche said Tuesday that its prescription medicine Alecensa has been approved in Switzerland as a first-line ...

Read more →

FDA approves drugs before EMA and Swissmedic, comparison finds

23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...

Read more →

Swissmedic accepts our filing for edaravone to treat ALS

23 January 2018 - Mitsubishi Tanabe Pharma Corporation announced today that the Swissmedic has accepted its filing for edaravone, an intravenous ...

Read more →

Swissmedic updates biosimilar guidance to allow comparators of US origin

11 January 2018 - The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in ...

Read more →