AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the ...

Committee for Medicinal Products for Human Use (CHMP) has recommended approving AstraZeneca’s Fasenra (benralizumab) to treat ...

Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been ...

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended an update to Novo Nordisk’s ...

The CHMP initially adopted a negative opinion in January after finding it was unable to establish a positive balance of benefits and risks for Syfovre, but Apellis sought a re-examination and was able ...

For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S.

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the European Medicines Agency's ...

Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a ...

Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen that ...

Extension of indication for Buccolam 10 mg to now include treatment of adults as well as childrenPaves way for the extension of well-established and pan-European market-leading brand to include the ...

Paris: Sanofi has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has ...

Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in ...