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The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
Viehbacher, "Biogen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti ...
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CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo
Bristol Myers BMY announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of Opdivo (nivolumab) for another ...
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CHMP recommends oral peanut allergy immunotherapy treatment for toddlers
The European Medicines Agency’s (EMAs) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of Stallergenes Greer’s oral immunotherapy, Palforzia (defatted ...
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 ...
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Committee for Medicinal Products for Human Use (CHMP)
The Committee is responsible for preparing the European Medicines Agency’s (EMA) opinions on all questions concerning medicinal products for human use, in accordance with Regulation (EC) No 726/2004.
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Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars
Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for ...
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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. Lilly said Friday that it hopes discussions about the drug continue with the ...
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European regulators reject Lilly’s US-approved Alzheimer’s treatment
The agency’s Committee for Medicinal Products for Human Use said Indianapolis-based Lilly can ask for a re-examination of its opinion. Lilly said Friday that it hopes discussions about the drug ...
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Italfarmaco Provides Overview on Givinostat as Treatment for Duchenne Muscular Dystrophy: Progress in Global Access, Regulatory Milestones and Clinical Trials
The European Medicines Agency (EMA) is currently reviewing the Marketing Authorisation Application (MAA), with a Committee for Medicinal Products for Human Use (CHMP) opinion expected in the first ...
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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. Lilly said Friday that it hopes discussions about the drug continue with the agency ...
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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. Lilly said Friday that it hopes discussions about the drug continue with the ...