The CHMP renders a positive opinion recommending approval for MRK's Keytruda for the first-line treatment of malignant ...

Statement/Regulatory AdmissionFormycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® 18.11.2024 / 06:30 ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...

Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. As per regulatory process, the European Commission is expected to make a final decision on the ...

BeiGene's TEVIMBRA expands for cancer treatment, and BRUKINSA sales soar 107%. See why BGNE stock presents upside potential ...

The CHMP in July recommended against approval of ... Japan's Eisai serves as the lead for Leqembi's development and regulatory submissions worldwide and co-commercializes the drug with Cambridge ...

Two kinase inhibitors have been recommended by the European Medicines Agency for the treatment of non-small cell lung cancer.

The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) ...

EMA committee recommends approval of Eisai & Biogen’s lecanemab to treat early Alzheimer’s disease: Tokyo Saturday, November 16, 2024, 13:00 Hrs [IST] Eisai Co., Ltd. and Biog ...

1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is ...