A wave of submissions has arrived at the US FDA amid the dawn of spring, as drugmakers filed at least five new molecular entities (NMEs) and new biological entities (NBEs) with the agency.
Keeping Track: Submissions Galore, Blincyto Supplemental Approval, And Priority Review For Opdivo/Yervoy Combo
The latest drug development news and highlights from our US FDA Performance Tracker.
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US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.
The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.