3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...
26 February 2021 - If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive ...
26 February 2021 - If approved, somatrogon will serve as a once-weekly treatment option. ...
26 February 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending dostarlimab, an anti-programmed ...
26 February 2021 - Evrysdi is approved in seven countries, submitted in 30 more. ...
25 February 2021 - BioCryst Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
24 February 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known ...
22 February 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...