AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma

27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...

Read more →

Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA

8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...

Read more →

Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)

31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...

Read more →

Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application

20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how ...

Read more →

FDA and EMA to hold workshop on breakthrough therapy and PRIME designations

2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...

Read more →

Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma

16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...

Read more →

Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma

20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia. ...

Read more →

Merck receives breakthrough therapy designation from FDA and PRIME status from EMA for investigational Ebola Zaire vaccine (V920)

25 July 2016 - Merck today announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live ...

Read more →