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Growth and Advancements in Fill/Finish
Leveraging automation advancements can help improve efficiency in aseptic processing.
Changes and Trends in the Outsourcing Landscape
Quality Considerations in Changing Excipient Providers
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 21, 2024
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.
Challenges in fermentation can be addressed through equipment changes, facility design, and process development.
AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.
GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.
February 20, 2024
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
February 17, 2024
Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.
February 16, 2024
In surplus and shortage, compounding amplifies all.
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.