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Results For "CHMP"

124 News Found

EU regulator backs Allergan Aesthetics’ Boey in key step toward approval
Drug Approval | May 25, 2026

EU regulator backs Allergan Aesthetics’ Boey in key step toward approval

The decision marks a key step in the centralized EU review process


Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva
Drug Approval | May 04, 2026

Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva

Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market


Moderna wins EU approval for first combined flu & COVID shot for adults 50+
Drug Approval | April 22, 2026

Moderna wins EU approval for first combined flu & COVID shot for adults 50+

The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states


EU nod to Rezurock for chronic GVHD in adults & teens
News | April 08, 2026

EU nod to Rezurock for chronic GVHD in adults & teens

Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation


EMA moves to cut animal testing with “virtual control groups” in preclinical research
Policy | April 03, 2026

EMA moves to cut animal testing with “virtual control groups” in preclinical research

The approach, which could significantly reduce the number of rats used in certain dose-range finding studies


Moderna wins EU backing for world’s first combined flu-COVID shot
News | March 02, 2026

Moderna wins EU backing for world’s first combined flu-COVID shot

The decision marks a pivotal moment for the Massachusetts-based biotech giant


Merck’s KEYTRUDA shows significant survival boost in platinum-resistant ovarian cancer
Clinical Trials | February 28, 2026

Merck’s KEYTRUDA shows significant survival boost in platinum-resistant ovarian cancer

KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients


Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss


Moderna’s new Covid vaccine mNEXSPIKE wins European approval
News | February 17, 2026

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe


STADA & Bio-Thera bag European nod for Gotenfia
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia