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Results For "European-Union"

191 News Found

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


Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation
Drug Approval | June 16, 2022

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

Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation


Takeda’s dengue vaccine candidate offers protection against dengue fever in clinical trial
Diagnostic Center | June 11, 2022

Takeda’s dengue vaccine candidate offers protection against dengue fever in clinical trial

TAK-003 is currently undergoing regulatory review for potential licensure in both the European Union


USFDA approves Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile


Lancet publishes results of Phase 3 programmes of Rinvoq in Ulcerative Colitis
Biotech | May 27, 2022

Lancet publishes results of Phase 3 programmes of Rinvoq in Ulcerative Colitis

Data from the three studies formed the basis of the company's application for approval by regulatory agencies


European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer
Drug Approval | May 25, 2022

European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer

This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC


Pfizer offers patent-protected medicines on not-for-profit to 45 low income countries
News | May 25, 2022

Pfizer offers patent-protected medicines on not-for-profit to 45 low income countries

Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap