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March 15, 2024
Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.
The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.
March 08, 2024
EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.
EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.
March 07, 2024
FDA has published final guidance documents regarding validation and development of analytical procedures.
March 03, 2024
This article explores the emergence of subjectivity in ICH Q9 (R1).
March 02, 2024
Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.
February 29, 2024
This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.
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.