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...
Federal Register notice: FDA rejects a request for a hearing submitted by Bernardo Garmendia, and issues an order permanently debarring him from provi...
Becton Dickinsons CareFusion unit recalls its BD Alaris Systems Manager due to software issues that could provide incorrect therapy.