GlobalData on MSN1d
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 for SARS-CoV-2-induced ARDS
InflaRx (IFRX) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive ...
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
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 ...
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.
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.
Pharmabiz6h
EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma
EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma: Paris Saturday, November 16, 2024, 09:00 H ...
precisionmedicineonline15h
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.
precisionmedicineonline15h
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 ...
PharmiWeb23h
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) ...
Pharmabiz2h
EMA committee recommends approval of Eisai & Biogen’s lecanemab to treat early Alzheimer’s disease
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 ...