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Results For "European-Commission"

123 News Found

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Diagnostic Center | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Drug Approval | November 11, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster

The European Commission will review the CHMP recommendation and is expected to make a final decision soon.


Inceptua Early Access and Sentynl Therapeutics launch early access program for Nulibry for pediatric patients
News | October 19, 2022

Inceptua Early Access and Sentynl Therapeutics launch early access program for Nulibry for pediatric patients

MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.


Tezspire approved in the EU for the treatment of severe asthma
Drug Approval | September 21, 2022

Tezspire approved in the EU for the treatment of severe asthma

First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations


Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
Drug Approval | September 21, 2022

Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19

Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial


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 approved in the EU as adjuvant treatment for early breast cancer
Drug Approval | August 04, 2022

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients


Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions
Drug Approval | June 29, 2022

Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions

Safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications1,2


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