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May 13, 2024
EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.
April 12, 2024
The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.
April 09, 2024
In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.
March 16, 2024
Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.
March 08, 2024
EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.
March 02, 2024
Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.
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.