GlobalData on MSN16h
EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...
Bristol Myers gets positive EMA opinion for repotrectinib
Bristol Myers Squibb (NYSE:BMY) has received a recommendation for approval from the Committee for Medicinal Products for ...
InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
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 Gets CHMP Backing for Augtyro Cancer Drug
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.
GlobalData on MSN1d
EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
precisionmedicineonline8h
EMA's CHMP Recommends Approval for First-Line Opdivo-Yervoy in Certain Colorectal Cancers
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.
Bristol Myers receives positive CHMP opinion for repotrectinib
Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended ...
Medscape10h
Leqembi Okayed for Subset of Early Alzheimer’s Patients
The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
precisionmedicineonline8h
CHMP Recommends BMS's Augtyro for ROS1-Positive NSCLC, NTRK-Positive Tumors
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 ...
Santé log4h
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) -- ...
Merck Gets CHMP Backing of Keytruda in Malignant Pleural Mesothelioma
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 ...