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Results For "European-Medicines-Agency"

193 News Found

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


Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)
News | March 18, 2022

Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)

The announcement follows recent authorization of the Company's mRNA COVID-19 vaccine in Australia and the European Union for children aged 6-11 years


Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry
Biotech | March 09, 2022

Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry

Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder


SII’s Covovax approved for 12-17 years age group
News | March 09, 2022

SII’s Covovax approved for 12-17 years age group

The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28th 2021


WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.


Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine
News | February 24, 2022

Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine

100% efficacy against severe Covid-19 disease and hospitalizations


Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine
Biotech | February 16, 2022

EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine

Apexxnar is the first pneumococcal conjugate vaccine to help protect adults ages 18 years and older against 20 serotypes responsible for the majority of invasive disease and pneumococcal pneumonia


Biohaven and Pfizer announce positive topline results of rimegepant to treat migrane
Biotech | February 14, 2022

Biohaven and Pfizer announce positive topline results of rimegepant to treat migrane

Rimegepant is the first oral calcitonin gene-related peptide receptor antagonist to demonstrate positive results in a pivotal trial in the Asia Pacific