Results (3617)
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).
NewsHumanMedicines
EMA has recommended granting a marketing authorisation in the European Union for a new therapy for the treatment of adult patients with amyotrophic lateral sclerosis (ALS), a rare and often fatal disease that causes muscles to become weak and leads to paralysis. Qalsody (tofersen) is indicated for the treatment of adults with ALS, who have a...
NewsHumanMedicines
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
NewsHumanMedicinesReferralsVaccines
Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.
NewsHumanVeterinaryAntimicrobial resistance
NewsVeterinaryMedicines
EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.
NewsHumanData on medicines
Paxlovid: reminder of serious adverse reactions when taken together with certain immunosuppressants
NewsHumanCOVID-19MedicinesPharmacovigilanceReferrals
Following the launch in September 2022, EMA has accepted three academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) into a pilot scheme, in which they benefit from enhanced support from the Agency.
NewsHumanAdvanced therapiesData on medicines