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Results For "European-Medicines-Agency"

172 News Found

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series


Moderna announces advancements in mRNA platform science for application across multiple diseases
Biotech | May 17, 2022

Moderna announces advancements in mRNA platform science for application across multiple diseases

Moderna continues to expand its mRNA platform for a range of additional clinical applications and routes of administration including a modality for lung delivery


CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment
Drug Approval | April 23, 2022

CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment

If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe


CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer
Biotech | April 23, 2022

CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer

With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


BioVaxys expands cancer vaccine platform
Biotech | March 31, 2022

BioVaxys expands cancer vaccine platform

BVX-0922 to target colorectal cancer under investigator-sponsored IND


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies


New spesolimab data show promising results in patients with generalised pustular psoriasis flares
Biotech | March 28, 2022

New spesolimab data show promising results in patients with generalised pustular psoriasis flares

Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months


CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma
News | March 25, 2022

CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma

Recommendation is based on pivotal data from the phase III POLARIX study