The CHMP's endorsement is based on outcomes from the pivotal Phase ... Discovered and developed by the company’s scientists, ...

The Scientific Advisory Group (SAG) has been called in to assist the EMA’s CHMP human medicines committee in its review of the drug, which is vying to become the first disease-modifying therapy ...

Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.

The CHMP has backed the drug as a treatment for ... at the data on the BCMA-targeted drug by its manufacturer. An EMA scientific advisory group concluded that the data available to date does ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...

The North Chicago, Ill., biopharmaceutical company said the European Commission, which generally follows the CHMP's advice, is expected to make a final decision in the first half of the year.

The European Medicines Agency’s (EMA) human medicines committee has recommended Krystal Biotech’s Vyjuvek (beremagene ...

Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...

Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for ...

Therefore, this positive CHMP opinion marks a crucial milestone toward introducing a more robust preventative solution against chikungunya in the EU. Broader accessibility will help provide ...

The CHMP's endorsement is based on outcomes from ... Discovered and developed by the company’s scientists, Rinvoq is a selective and reversible Janus kinase inhibitor under investigation for ...