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Results For "CHMP"

95 News Found

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares
News | October 17, 2022

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares

CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU
News | September 05, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine


Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer
Drug Approval | June 28, 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients


CHMP recommends European Commission approval of Rinvoq
Drug Approval | May 23, 2022

CHMP recommends European Commission approval of Rinvoq

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients


Novartis Cosentyx receives positive CHMP opinion for use in childhood arthritic conditions
Biotech | May 21, 2022

Novartis Cosentyx receives positive CHMP opinion for use in childhood arthritic conditions

Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU


CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment
Drug Approval | April 23, 2022

CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment

If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe


CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer
Biotech | April 23, 2022

CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer

With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma
News | March 25, 2022

CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma

Recommendation is based on pivotal data from the phase III POLARIX study


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.