GlobalData on MSN13h
EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma
Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade ...
InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
JENA, Germany, Nov. 15, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory ...
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 ...
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
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.
precisionmedicineonline4h
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 ...
Medscape6h
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 ...
PharmiWeb12h
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) ...
Santé log21m
Samsung Bioepis Receives Positive CHMP Opinion for Denosumab Biosimilars, OBODENCE™ and XBRYK™
OBODENCE™ and XBRYK™ recommended for approval by the European Medicines Agency for all indications referencing Prolia and Xgeva, respectively INCHEON, South Korea, Nov. 15, 2024 (GLOBE NEWSWIRE) -- ...
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...