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Manufacturing challenges set back development progress of cell therapies in oncology

Pharmaceutical Technology

Meanwhile, the drug's closest TIL competitor, Iovance Biotherapeutics’ lifileucel, has begun a rolling BLA for advanced melanoma patients and could reach the market as early as Q3 2023. In April this year, the FDA provided new feedback on the potency assays, which Iovance indicated will be addressed in the latest BLA.

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Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Medgadget

Currently, the awkwardness of conventional laparoscopic tools keeps many physicians from using them in a variety of cases. Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. are still done in an open fashion.

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Alpha TAU Killing Tumors With Highly Targeted Alpha Radiation

Medgadget

To make implantation of the Alpha DaRT sources easy and precise, the company developed dedicated applicators andadapted existing biopsy devices, that physicians are already acquainted with, to deliver the radioactive sources. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S.