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May 02, 2023
Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.
The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
April 28, 2023
The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.
clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.
April 26, 2023
The results found that repeatability testing found all 15 processes to be with in specification for target final concentration.
April 25, 2023
Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.
The leaked study summary found that Carvykti (ciltacabtagene autoleucel) reduced disease progression by 74%.
April 24, 2023
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.
BioChain has reached partnerships with NanoString and 10x Genomics to extend its spatial multiomics services.