Keyword: European Medicines Agency
NIIMBL is awarding $32 million in grants for a varied list of projects for improving biologics manufacturing, including for CAR-T drugs.
To make sense of Sanofi's Dengvaxia experiences, look no further than the old adage: Learn from your mistakes.
French inspectors found a lot they didn’t like about an Indian manufacturer, leading the EMA to cite the facility.
European regulators are banning heparin from a Chinese facility after finding contamination risks with its production of the anticoagulant.
Roche’s I-O rivals are hurtling toward a showdown in kidney cancer. But the Swiss drugmaker has decided to pull its horse out of the race.
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.