Go or no go? Pdufa resolutions eyed for J&J and Amryt
February will also see an outcome for Gilead's long-acting HIV therapy, and a key FDA panel for me-too checkpoint MAbs.
Go or go go? J&J’s cell therapy heads to the FDA
November approval decisions loom for cilta-cel and Voxzogo, while molnupiravir heads for an advisory panel.