An Elucid 510(k) gains clearance for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease.
A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug contract manufactur...
FDA updates CDRHs Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination requests.
FDA says that 22% of new molecular entities required postmarketing requirements or postmarketing commitments to address knowledge gaps on drugdrug int...
Johnson & Johnson discontinues a Phase 2 study evaluating mosnodenvir for preventing dengue virus in adults aged 18-65 years.
FDA says the shortage of Lillys Mounjaro and Zepbound has been resolved but other similar products remain in short supply.
FDA lifts a partial clinical hold on Avidity Biosciences delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for treating myotonic d...
FDA has released the form FDA-483 with five observations from an inspection at the Lakewood, CO-based BSO outsourcing facility.
