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Results For "European-Union"

191 News Found

Merck and Eisai present results from Phase 3 LEAP-002 Trial evaluating KEYTRUDA
Diagnostic Center | September 12, 2022

Merck and Eisai present results from Phase 3 LEAP-002 Trial evaluating KEYTRUDA

Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022


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


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise


Bayer showcases cancer study data at ESMO Congress 2022
News | September 01, 2022

Bayer showcases cancer study data at ESMO Congress 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

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


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


QIAGEN launches syndromic test for QIAstat-Dx device to combat Monkeypox health emergency
News | August 16, 2022

QIAGEN launches syndromic test for QIAstat-Dx device to combat Monkeypox health emergency

QIAstat-Dx Viral Vesicular Panel tests for six pathogens that produce similar symptoms


Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate
Diagnostic Center | July 28, 2022

Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate

This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.


Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine
News | June 30, 2022

Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses


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