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...
Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they told the agency that the drugs were no longer marke...
