Keyword: European Medicines Agency
EMA inspectors have uncovered big manufacturing and quality concerns at sterile injectables plant of Genfarma Laboratorio in Spain.
India’s Mercury Laboratories intends to boost its exports but an EMA report shows regulators aren't impressed with what the company is doing now.
Sanofi's beleaguered dengue vaccine is expected to win European approval in December following a committee's vote in favor of the shot this week.
EU regulators say they have found the same impurity discovered in valsartan in both losartan and irbesartan.
The EMA has taken action against China’s Zhejiang Huahai, whose valsartan API has been found to contain a suspected carcinogen.
The organizations saw the article’s method as problematic, as it relies solely on suspected adverse reactions reports received from different geographies.
The EMA says concerns over drug shortages stemming from Brexit have eased, but not all drugmakers feel the same.
Emgality will likely chase Amgen and Novartis’ first-in-class Aimovig and Teva's Ajovy in the CGRP migraine field.
After more than 50 years in Arnhem, the Netherlands, Novartis is moving its Dutch operations to Amsterdam, the EMA's future home.
Jiangsu Yew Pharma had its European marketing authorization suspended for refusing to allow inspectors into a manufacturing facility.