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EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
News
Human
Medicines
Referrals
Vaccines
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).
News
Human
Medicines
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...
News
Human
Medicines
Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria. This is according to the fourth joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance (AMR) in bacteria from humans and food...
News
Human
Veterinary
Antimicrobial resistance
News
Veterinary
Medicines
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.
News
Human
Data on medicines
Paxlovid: reminder of serious adverse reactions when taken together with certain immunosuppressants
News
Human
COVID-19
Medicines
Pharmacovigilance
Referrals
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.
News
Human
Advanced therapies
Data on medicines
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.
News
Human
Clinical trials
Medicines
EMA has just launched the new Antimicrobial Sales and Use (ASU) Platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.
News
Veterinary
Antimicrobial resistance