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Results For "European"

924 News Found

European Commission expands Jemperli plus chemotherapy approval for endometrial cancer
Drug Approval | January 21, 2025

European Commission expands Jemperli plus chemotherapy approval for endometrial cancer

Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population


European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors
Drug Approval | November 21, 2024

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors


European Food Safety Authority confirms safety of silica as food additive
News | October 23, 2024

European Food Safety Authority confirms safety of silica as food additive

Silica is a proven and highly effective anti-caking agent that has been used for decades


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


Sumitomo Pharma presents new clinical data on DSP-5336 at the European Hematology Association 2024 Congress
News | June 20, 2024

Sumitomo Pharma presents new clinical data on DSP-5336 at the European Hematology Association 2024 Congress

DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia


Biocon's European partner Zentiva receives approval from UK MHRA for Liraglutide
Drug Approval | April 01, 2024

Biocon's European partner Zentiva receives approval from UK MHRA for Liraglutide

The company had earlier announced about the approval received from the MHRA for Liraglutide


Syngene biologics facility to be operational for US, European customers from mid-year
News | March 17, 2024

Syngene biologics facility to be operational for US, European customers from mid-year

New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day


European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
Drug Approval | March 13, 2024

European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally