FDA clears a ConforMIS 510(k) for the iTotal Hip replacement system.
FDA clears a Medicrea Group 510(k) for UNiD HUB, a data-driven digital portal for the companys Adaptive Spine Intelligence.
Seattle Genetics says it is discontinuing its Phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leu...
FDA issues a draft guidance on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry on Pharmacogenomic Data Submissions; ...
Alvogen recalls seven lots of clindamycin injection USP ADD-Vantage Vials due to microbial growth detected during a routine simulation of the manufact...
Datascope Corp. begins a field correction involving certain Intra-Aortic Balloon Pumps due to a potential electrical test failure code.
Federal Register notice: FDA proposes a new drug advertising study entitled Experimental Study of Risk Information Amount and Location in Direct-to-Co...