VectorBuilder Powers FDA IND Approval of World’s First Umbilical Cord Blood-Derived Allogeneic CAR-T Product
VectorBuilder's partner, Ucello, announced that its CD19-targeting umbilical cord blood-derived allogeneic CAR-T cell therapy ...
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FDA testing aged raw cow’s milk cheese for bird flu
the FDA said the goal of testing will be two-fold: detecting the H5N1 virus and taking the necessary follow-up actions to protect consumers. Raw, unpasteurized milk is a known vector of bird flu ...
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US judge blocks FDA graphic warning label requirement for cigarettes
The FDA argued the law gave it the authority to ... Imperial Brands' (IMB.L), opens new tab subsidiary ITG Brands and Vector Group's Liggett Group unit. R.J. Reynolds and the FDA declined to ...
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FDA approves Adstiladrin as first gene therapy for NMIBC
The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring ... (cannot multiply in human cells) adenoviral vector-based gene therapy. Its safety and efficacy was evaluated ...
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Spur Therapeutics, FDA Align on Phase III Plans for Gaucher Disease Gene Therapy
The FDA has offered positive feedback on possible paths forward for accelerated or traditional approval of FLT201 using data from a single-arm study.
Pluristyx Announces Filing of Drug Master File for PluriBank™ iPSC Lines with U.S. FDA
Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration ...