Keyword: CHMP

Novartis’ Zolgensma launch has been anything but boring: First a record price, then a data scandal and now a manufacturing-related delay in Europe.

Painted as the follow-up drug to Humira, AbbVie’s JAK med Rinvoq has blockbuster hopes in mind. An early nod in the EU could help it reach that goal.

At its July meeting, experts with the European Medicines Agency's CHMP recommended approvals for four novel drugs, a Mylan generic and more.

Mitsubishi Tanabe’s Radicava touted its FDA approval as a win for ALS patients. But on the clinical data that backed it, the EU wants to see more.

The likely EU approval of Bluebird's gene therapy to treat transfusion-dependent β-thalassemia has renewed speculation about pricing.

The EMA initially rejected Xeljanz's application in 2013 out of safety concerns, only to change its mind in 2017.

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.

While Seqirus works to boost manufacturing for its cell-based flu vaccine in the U.S., the shot is nearing an approval in Europe.

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.

Emgality will likely chase Amgen and Novartis’ first-in-class Aimovig and Teva's Ajovy in the CGRP migraine field.