Keyword: European Medicines Agency
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.
Merck’s Keytruda is one step closer to extending its dominance in the all-important previously untreated lung cancer market.
The EMA is taking action against an Italian CDMO after inspectors found what they called major deficiencies in its production of sterile drugs.
With Brexit looming, AstraZeneca has taken up three lines of defense to forestall potential supply disruptions.
Biogen and Eisai's anti-amyloid candidate shows promise; Otsuka signs two M&A deals; Samsung BioLogics faces criminal probe over Biogen JV agreement.
Zhejiang Huahai Pharmaceutical informed the EMA that it had identified a chemical that might lead to cancer in its valsartan provided to the European market.
Gilead and Novartis CAR-T cancer drugs Yescarta and Kymriah won an EMA committee backing for marketing approval.
French regulators issued a warning letter to Indian API maker Dhanuka Labs after inspectors found a risk for product contamination.