Filings both for the obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination submitted to EMA by our partner, Menarini, for treatment of adults with primary hypercholesterolemia ...

Sanofi has received orphan designation from the European Medicines Agency (EMA) for rilzabrutinib, a reversible covalent ...

The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.

Culver City-based ImmunityBio Inc. has started to take its Anktiva immunotherapy drug global. Last month, the United Kingdom ...

Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men.

Ascentage Pharma (AAPG) announced that it has received clearance by the U.S. Food and Drug Administration, FDA, and the European Medicines Agency, ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

UPDATED: Friday, July 11 at 8:50 a.m. ET After a review by the safety committee of the European Medicines Agency, the regulator is removing a temporary restriction on Valneva's chikungunya vaccine.

Launching in 2025, the European Platform for Regulatory Science Research will bring together academia, regulators and other stakeholders to accelerate collaborative regulatory science research ...