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.
Having achieved a turnaround in its R&D and commercial fortunes, AstraZeneca’s hopes the opening of a new research center will herald its next wave of novel therapies.
Pfizer and BioNTech’s Comirnaty supply under existing agreements will continue as planned despite anticipated expansion into a new child sub-population in Europe.