February 20, 2017
Mereo BioPharma’s rare bone disease drug to develop sooner
Mereo BioPharma’s bone disease drug BPS-804 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways programme.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: EMA
February 6, 2017
Ablynx submits its thrombosis antibody to EMA
Ablynx has applied its caplacizumab to European Medicines Agency for approval to use it for a form of blod clotting disorder.
February 1, 2017
Biomarin’s hemophilia drug nets PRIME status in Europe
BioMarin Pharmaceutical’s treatment for hemophilia has been accepted for PRIME (Priority Medicines) scheme from the European Medicines Agency (EMA).
December 23, 2016
TiGenix submits Day 120 Responses to EMA for Crohn`s disease drug
TiGenix has submitted its responses to the European Medicines Agency`s (EMA) Day 120 List of Questions for Cx601, its lead…
December 19, 2016
Hungarian Richter withdraws biosimilar drug marketing authorisation application from EMA
Gedeon Richter Plc., a Hungarian drugmaker has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for…
December 16, 2016
Novartis’s epilepsy drug gets CHMP’s positive opinion
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for…
November 3, 2015
Janssen Applys to EMA to Expand Use of Imbruvica
Janssen-Cilag International NV announced on Tuesday the submission of a Type II variation application to the European Medicines Agency (EMA) seeking…
October 5, 2015
Cell Therapy applies for CMA for Heartcell
Cell Therapy Ltd will begin the application process for a conditional marketing authorisation (CMA) for Heartcel, the first allogeneic stem cell therapy to regenerate the human heart, in Europe.
September 26, 2015
Janssen’s daratumumab accepted for treatment of European patients with heavily pre-treated multiple myeloma
Janssen-Cilag International NV has announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European…