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CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo
BMY obtains CHMP recommendation for Opdivo for perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by ...
Halozyme: Bristol Myers receives positive CHMP opinion for Opdivo/Enhanze
Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products ...
BeiGene receives positive CHMP opinion for Tevimbra
BeiGene (ONC) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion ...
Fierce Pharma4d
Eli Lilly's Alzheimer's contender Kisunla gets thumbs-down from EU regulators over safety concerns
After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease ...
European committee says Lilly Alzheimer's drug shouldn't get marketing approval
A European regulatory committee has rejected Eli Lilly's U.S.-approved Alzheimer's disease treatment over potentially ...
The Pharma Letter19h
EC refers lecanemab decision to Appeal Committee
Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) today provided an update on the ongoing regulatory review of the Marketing ...
The European Commission refers lecanemab decision to Appeal Committee
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab in the ...
Medical Dialogues3d
Bristol Myers Squibb gets Positive EMA Committee opinion for subcutaneous formulation of Opdivo across Multiple Solid Tumor Indications
Princeton: Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ...
Medscape6d
EMA Approves AI Tool for MASH Clinical Trials
The tool reduces pathologist variability in liver biopsy assessment during trials of treatments for metabolic ...
Sydnexis, Inc.: Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of Pediatric Myopia
Santen is Sydnexis' Licensing Partner to Commercialize SYD-101 within the EMEA Region upon issuance of a Marketing Authorization by the European Commission Sydnexis, Inc. ( a pre-commercial ...
Medical Dialogues2d
Bristol Myers Squibb receives positive EMA Committee opinion for Perioperative Opdivo plus Chemo in Resectable Non-Small Cell Lung Cancer plus PD-L1
Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...