Keeping Track: US FDA Clears Another CAR-T And Another Novel ADHD Drug; Submissions Blossom
The latest news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Idecabtagene vicleucel for fifth-line multiple myeloma lags GSK’s BCMA-targeting ADC Blenrep, but it is months ahead of J&J/Legend’s CAR-T. Abecma is BMS’s second CAR-T approval this year.
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.
Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.