OR WAIT null SECS
January 14, 2019
The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.
January 04, 2019
In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.
January 02, 2019
Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.
As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.
January 01, 2019
This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.
December 20, 2018
Sanofi has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the EMA's CHMP
December 05, 2018
The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.
NICE has recommended the use of regorafenib as a treatment for NHS patients with advanced liver cancer, following consideration of a new commercial arrangement.
Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).
Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.