Results (3623)
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.
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Outcomes of the EMA Management Board meeting. The Management Board is an integral governance body of the Agency.
NewsHumanCorporateClinical trialsFees
EMA has recommended granting a marketing authorisation in the European Union (EU) for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited.
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EMA has recommended granting a marketing authorisation in the European Union (EU) for Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.
NewsHumanMedicines
EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
NewsHumanMedicinesReferrals
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU).
NewsHumanClinical trials
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting.
NewsVeterinaryMedicines
PRAC finds no link between mRNA COVID-19 vaccines and postmenopausal bleeding
NewsHumanCOVID-19MedicinesPharmacovigilanceReferrals
The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.
NewsHumanData on medicines
EMA has recommended granting a marketing authorisation in the European Union (EU) for Voydeya, the first oral treatment for patients with paroxysmal nocturnal haemoglobinuria (PNH) who continue to have haemolytic anaemia (low levels of red blood cells) despite treatment with a C5 complement inhibitor (eculizumab or ravulizumab).
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