Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative.” The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.
A pioneering approval filing for a therapeutic app by Shionogi is set to herald expansion of ADHD therapies beyond the pill in Japan, along with growth in the pediatric segment for the disorder.