The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended ...

Merck (MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion ...

Bristol Myers Squibb (BMY) has received a recommendation for approval from an expert panel of the European Medicines Agency ...

The full indication for vilobelimab is as a treatment for adult patients with SARS‑CoV-2‑induced ARDS who are receiving ...

Eisai Europe Ltd. and Biogen Inc. announced today that a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...

The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...

Statement/Regulatory AdmissionAflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA15-Nov-2024 / 18:18 CET/CESTDisclosure of an inside information acc. to Article ...

Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its Augtyro cancer drug in a pair of indications.

The U.S. Food and Drug Administration approved the Keytruda combination in malignant pleural mesothelioma in September. Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.