Incyte says it will file an NDA for its JAK1 inhibitor povorcitinib and its use in adult patients with moderate to severe hidradenitis suppurativa, an...
Three former executives of Magellan Diagnostics plead guilty to federal charges after concealing a medical device malfunction involving lead test resu...
Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an allogeneic T-cell immunotherapy, in certain leukemia patients met its primary endpoi...
FDA lifts a clinical hold against vTv Therapeutics cadisegliatin clinical program evaluating the first-in-class oral adjunctive therapy to insulin for...
AstraZeneca reports positive data from the CALYPSO Phase 3 hypoparathyroidism trial, showing eneboparatide met its primary endpoint.
Thousands of FDA employees return to their offices 3/17 and deal with logistical issues, such as traffic, parking and finding work spaces.
FDA warns healthcare professionals about supply interruptions involving hemodialysis bloodlines.
Federal Register notice: FDA withdraws the approval of a Sage Therapeutics NDA for Zulresso (brexanolone) solution after it told the agency that the d...
