September batch of EMA/CHMP novel drug approval recommendations

15 September 2023

Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines.

The CHMP recommended granting a marketing authorization for Spanish drugmaker Almirall’s (BME: ALM) Ebglyss (lebrikizumab), for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents.

A positive opinion was adopted for Finlee (dabrafenib), from Swiss pharma giant Novartis (NOVN: VX), for the treatment of glioma, a type of brain tumor that begins in glial cells, the cells that surround and support nerve cells.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK