FDA issues CRL for EMD Serono Cladribine tablets NDA
FDA said the CRL was issued based on the results from Clarity study. However, the FDA has requested EMD Serono to provide an improved understanding of safety risks
Mediar Therapeutics has announced a collaboration and option agreement with Ono Pharmaceutical to develop new treatments for fibro-inflammatory diseases.
The study is a 19-week follow-up, multicentre, double-blind, randomised, placebo-controlled, parallel-group study in subjects with MS spasticity not fully relieved with current anti-spasticity therapy. The trial result suggested