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Results For "European-Medicines-Agency"

257 News Found

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


Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020


Aurobindo’s CuraTeQ and Orion expand licencing deal in select European markets
News | January 11, 2022

Aurobindo’s CuraTeQ and Orion expand licencing deal in select European markets

CuraTeQ and Orion had entered into a licensing agreement, granting marketing and distribution rights for CuraTeQ’s biosimilar products under development in the Nordic states, Austria, Hungary and Slovenia


CDSCO expert committee recommends Emergency Use Authorisation to Covovax and Corbevax
News | December 28, 2021

CDSCO expert committee recommends Emergency Use Authorisation to Covovax and Corbevax

All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease