Feature|Videos|January 2, 2025
FDA Regulations for CAR T-cell Therapy
Examining hurdles surrounding FDA approval and how to streamline the process
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Episodes in this series
The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain. Panelists examine their own strategies that have increased collaboration and support from the FDA.
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Gilead agrees to acquire an oral IL-23R inhibitor from PepStar, while Zymeworks licenses its DLL3-targeting T cell engager ZW209 to Roche.
Incubate’s John Stanford on why MFN is voluntary in name only — and why the moonshot is the first casualty of drug pricing pressure.
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Median Drug Launch Prices Hit $257,000 as Access Barriers Persist, ICER and West Health Report Finds
Median net launch prices for new drugs climbed between 2022 and 2025 to $257,000, according to a new ICER and West Health report that also found persistent coverage and access barriers for patients.
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Roundup: Gilead Acquires Oral IL-23R Inhibitor From PepStar for $1.275 Billion, Zymeworks Licenses DLL3-Targeting T Cell Engager to Roche
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FDA Approves Hibsago (Bepirovirsen) for Chronic Hepatitis B
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FDA Grants Ultomiris Accelerated Approval in the U.S. for Adults with Primary Immunoglobulin A Nephropathy
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Pharmaceutical Executive Daily: FDA Grants Ultomiris Accelerated Approval in the U.S.
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