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March 08, 2024
EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.
February 28, 2024
Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.
February 27, 2024
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
February 23, 2024
Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.
February 17, 2024
Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.
February 16, 2024
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
February 12, 2024
The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.
February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.