Marketing Authorization

Nezglyal remains 'promising' therapy despite EMA’s market authorization refusal

29-Feb-2024 By Isabel Cameron

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently refused marketing authorization for Nezglyal (leriglitazone).

TG Therapeutics and Neuraxpharm sign $650 million commercialization deal for multiple sclerosis treatment

03-Aug-2023 By Isabel Cameron

TG Therapeutics and Neuraxpharm have announced an agreement for the ex-US commercialization of BRIUMVI (ublituximab).

Regeneron and Sanofi’s PD-1 inhibitor given go-ahead by EC

04-Jul-2019 By Maggie Lynch

Regeneron and Sanofi’s Libtayo is granted marketing authorization by the European Commission for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.

EU rules Avastin can be reimbursed for off-label use

30-Nov-2018 By Maggie Lynch

The European Court of Justice has determined that Roche’s Avastin may be reimbursed for ARMD – despite Novartis and Bayer’s challenge.

EMA gives positive opinion on Keytruda as adjuvant therapy

26-Oct-2018 By Maggie Lynch

MSD announced that the EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.