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Minoryx Therapeutics and the Neuraxpharm Group enter into a license agreement for the European rights to leriglitazone, which is currently under EMA review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD).
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
The European Medicine Agency has launched a six month consultation on the principles that will form the basis of the electronic product information (ePI)...
First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes...
10 March 2017 | By Steve Bremer, Managing Editor
Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe. One of the tools discussed was the scientific assessment of medicines or vaccines for use…
12 January 2017 | By Niamh Marriott, Digital Editor
This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers...
30 October 2013 | By Johnson & Johnson
“The EMA Marketing Authorisation Application is an important milestone in the development of ibrutinib...”
16 March 2012 | By Novartis
Potential first pharmacological treatment for symptomatic vitreomacular adhesion...
