A long-awaited reckoning for Biogen's Alzheimer's drug and the review of AstraZeneca's coronavirus vaccine are among the top FDA decisions expected before the end of June.
Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.
One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses.
The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.
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