24 June 2022 - Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and ...
24 June 2022 - EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) ...
24 June 2022 - EMA’s CHMP recommended nine medicines for approval at its June 2022 meeting. ...
24 June 2022 - Recommendation is based on week 26 data from the CAPELLA trial showing twice yearly lenacapavir achieved high ...
24 June 2022 - ...
23 June 2022 - Filsuvez will be the first and only approved treatment for epidermolysis bullosa patients. ...
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...
20 June 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...
17 June 2022 - Speaking about the waiver, EFPIA Director General, Nathalie Moll said. “The decision is a serious retrograde step ...