Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
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) recommending authorisation of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment for
Samsung Bioepis Receives Positive CHMP Opinion for Denosumab Biosimilars, OBODENCEâ„¢ and XBRYKâ„¢
OBODENCEâ„¢ and XBRYKâ„¢ recommended for approval by the European Medicines Agency for all indications referencing Prolia and Xgeva, respectively INCHEON, South Korea, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co.
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EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myelomaThe European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...
Bristol Myers Squibb (NYSE:BMY) has received a recommendation for approval from the Committee for Medicinal Products for ...
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Committee for Medicinal Products for Human ...
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.
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
Patients with MSI-high/dMMR advanced colorectal cancers had a 79 percent lower risk of disease progression or death on Opdivo-Yervoy compared to chemo.
Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended ...
Two kinase inhibitors have been recommended by the European Medicines Agency for the treatment of non-small cell lung cancer.
The US Food and Drug Administration approved Augtyro in 2023 for the treatment of ROS1-positive advanced NSCLC. Earlier this year, the FDA also approved the drug for adult and pediatric patients 12 ...
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