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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 ...
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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 ...
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Johnson & Johnson’s Tremfya recommended by CHMP to treat Crohn’s disease
Johnson & Johnson (J&J) has announced that its Tremfya (guselkumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease (CD).
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Novo Nordisk gets CHMP backing for obesity drug Saxenda
Novo Nordisk has won a Committee for Medicinal Products for Human Use (CHMP) endorsement for a higher-dose version of its diabetes drug liraglutide that can be used to treat obesity. The Danish ...
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CHMP Recommends Against Approval of Eli Lilly's Kisunla Alzheimer's Drug
The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday adopted a negative opinion on Kisunla, citing the risk of potentially fatal events due to amyloid-related ...
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Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications
PRINCETON, N.J., March 28, 2025--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
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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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Eli Lilly's Alzheimer's contender Kisunla gets thumbs-down from EU regulators over safety concerns
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against a marketing authorization for the drug’s use in early symptomatic Alzheimer’s disease.
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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 ...
KENS25d
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 ...