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Results For "European-Commission"

201 News Found

Merck’s Welireg receives European approval for two indications
News | February 19, 2025

Merck’s Welireg receives European approval for two indications

WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma
News | February 01, 2025

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population


Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals
News | December 31, 2024

Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals

Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million


Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Clinical Trials | September 20, 2024

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma


Roche’s PiaSky approved in the EU for treatment of people with PNH
Drug Approval | September 03, 2024

Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


EC approves Ordspono for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
Drug Approval | August 27, 2024

EC approves Ordspono for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma

Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission