5 FDA decisions to watch in the fourth quarter

The next three months could bring a raft of important Food and Drug Administration decisions.

The agency is set to decide on new genetic medicines for sickle cell disease, including what would be the first CRISPR-based treatment cleared in the U.S. Expanded use of a multiple myeloma cell therapy is also on the table, as is a confirmatory approval for Amgen’s KRAS-targeting lung cancer drug Lumakras. And within the week, the regulator will issue a verdict that could help Alnylam Pharmaceuticals finally turn a consistent profit.