FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.
FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate ...
AdvaMed says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices it identifies.
FDA requests comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute data elements for t...
Medtronic recalls (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations.
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.
