European Medicines Agency

Puma Biotechnology Inc said on Tuesday a committee of the European Medicines Agency was likely to give positive opinion on its breast cancer drug, five months after the regulator recommended against approving it. Puma shares were...

EMA has accepted the application under a special procedure called “Article 58” which allows the EMA to give a scientific opinion, in co-operation with the World Health Organization (WHO), for the evaluation of medicinal products that...

News Hour: Novartis announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for AMG 334 (erenumab) for the prevention of a migraine. Erenumab is an anti-CGRP monoclonal antibody developed to prevent a...

News Hour: A European Medicines Agency (EMA) panel recommended on Friday approving Novartis’s Kisqali drug, bolstering the Swiss drugmaker’s bid to challenge rival Pfizer’s Ibrance against tough-to-treat breast cancer. The EMA’s Committee for Medicinal Products for...