Tag: European Commission

ORION CORPORATION
PRESS RELEASE
21 JULY 2025 at 10:30 EEST          

– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –

– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –

- Presentations highlight clinically meaningful reductions in BMI in patients with acquired hypothalamic obesity –

Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva’s single-dose chikungunya vaccine IXCHIQ^® by EMA’s safety committee (PRAC).

Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026

Data from Orbit and Cosmic studies expected around the end of the year