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The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
February 22, 2024
Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.
February 21, 2024
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.
February 20, 2024
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
February 16, 2024
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
February 15, 2024
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
February 04, 2024
NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.
February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.