European Medicines Agency
Despite a frantic effort to rush Ebola vaccines through testing during an epidemic, Merck will fall short in its goal to file its candidate this year.
With all eyes fixed on Monday's vote for the European Medicines Agency relocation, Milan and Amsterdam emerged as top picks.
With time running short, EU members have been asked to set aside parochial interests in their pick for a new city to host the EMA.
Novartis is blazing ahead with its bid to take its CAR-T therapy Kymriah into new realms with a double-pronged application in Europe.
Merck surprised investors Friday with news that it had pulled its application for a new Keytruda combo in lung cancer. They didn't take it well.
Dr. Reddy's recalls more meds in the U.S., while the EMA recanted its plant's GMP certificate; China approved a domestic Ebola vaccine.
A report by the European Medicines Agency lays out the reason why German regulators pulled the GMP certificate from a Dr. Reddy's plant in India.
As the EMA prepares to move, officials have unveiled the list of cities staffers say would keep them around.
Biocon says it has won EMA manufacturing approval for a $275 million plant in Malaysia where it will make insulin for export to the EU.
Mylan and Biocon, whose Herceptin biosimilar was to be considered by the FDA Sept. 3, has had its target date delayed three months.