JAK inhibitor Rinvoq (upadacitinib) has been backed by the CHMP as a 15mg ... although men with the disease are more likely to develop visual symptoms. The European Commission should now give ...

which leads to severe and irreversible visual impairment and blindness," said Marci English, Astellas head of biopharma and ophthalmology development. "While we are disappointed with the CHMP's ...

Late last week, you guys got the positive CHMP opinion, and Christel previously guided to a ... Ritu Baral, Analyst, TD Cowen: Yeah. Yes. Is it, you know, visual acuity? Or Krish Krishnan, CEO, ...

The commission last month asked the CHMP to consider whether the new information would require an update of the positive opinion, and to consider whether the wording of the risk minimization ...

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.

STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP ...

(RTTNews) - Regeneron Pharmaceuticals (REGN) announced the CHMP has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and ...

The European Commission (EC) will now review the CHMP recommendation, and a decision on the label extension application of IXCHIQ ® in the European Union (EU), Norway, Liechtenstein and Iceland is ...

EU Health Regulator Clears Use of AI Tool in Fatty Liver Disease Trials (Reuters) -A European Medicines Agency committee, on Thursday, accepted the use of an artificial intelligence (AI) tool ...

announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) in combination with gemcitabine and ...

Orphelia Pharma is exploring alternative regulatory pathways for Kizfizo (temozolomide) following a negative opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for ...