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

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

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

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated ...

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

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.

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 ...

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.

Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the ...