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April 24, 2024
FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.
April 22, 2024
A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.
Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile powder transfer of parenteral drug products.
Andreas Frerix, product management director for Quattroflow at PSG Biotech, discussed the advantages and new challenges SUTs present for pumping systems.
April 19, 2024
Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.
April 18, 2024
The improvement of ADC manufacturing now demands increased containment requirements and continually advancing analytical detection of molecules in manufacturing spaces.
April 17, 2024
Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.
Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.
April 15, 2024
C3TI will promote CDER’s clinical trial innovation activities both internally and externally.
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.