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June 27, 2024
No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.
June 26, 2024
Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.
June 24, 2024
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
A new initiative will advance access to quality medicines and vaccines in Africa.
June 20, 2024
The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.
June 19, 2024
PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.
June 18, 2024
Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.
Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.
June 10, 2024
The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.