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Results For "Committee-for-Medicinal-Products-for-Human-Use"

116 News Found

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


Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer
Drug Approval | June 24, 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally


Vaxzevria approved in the EU as third dose booster against Covid-19
Drug Approval | May 23, 2022

Vaxzevria approved in the EU as third dose booster against Covid-19

Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine


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


NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency
Biotech | April 23, 2022

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers


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


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months