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Results For "European-Union"

187 News Found

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


Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron
News | June 27, 2022

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine


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


AstraZeneca and Merck announces results from phase 3 PROpel trial of Lynparza
News | June 22, 2022

AstraZeneca and Merck announces results from phase 3 PROpel trial of Lynparza

LYNPARZA is approved in the U.S. for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations)


Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation
News | June 18, 2022

Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation

Both manufacturing facilities are based out of Benguluru, India