Keyword: European Medicines Agency
The EMA initially rejected Xeljanz's application in 2013 out of safety concerns, only to change its mind in 2017.
The European Medicines Agency has found issues at the plant of an Indian API maker that the FDA hit with a warning letter some years back.
Just one week after a surprise trial failure, the FDA advised docs not to start new patients on Eli Lilly's soft tissue sarcoma drug Lartruvo.
Officials in Europe quickly responded to a trial failure for Lilly's Lartruvo, saying no new patients should start on the drug.
The European Medicines Agency has taken action against a Slovakian sterile drugmaker after inspectors tallied up nearly two dozen issues.
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.