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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 ...
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 ...
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 ...
Yahoo Finance4d
European committee says Lilly Alzheimer's drug shouldn't get marketing approval
The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion.
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 ...
Bristol Myers Gets CHMP Backing for Subcutaneous Opdivo
Bristol Myers Squibb said a key European regulatory committee is backing a formulation of its blockbuster cancer drug Opdivo that can be injected under the skin.