FDA accepted a supplemental New Drug Application and granted Priority Review for Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1-mutated relapsed or refractory myelodysplastic syndromes. If approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset.
An FDA advisory panel has recommended approval of Moderna’s mRNA-based flu vaccine, mFlusiva, for adults ages 50-64, and adults 65 and older, if a specific condition is met.
