FDA approvesd an expanded indication for Edwards Lifesciences Sapien 3 Transcatheter Heart Valve for patients with symptomatic heart disease due to fa...
A just-concluded inspection of Strides Shasum Ltd. in Bangalore, India has resulted in a three-item Form-483 citing GMP deficiencies concerning finish...
FDA commissioner Scott Gottlieb brings on three former Capitol Hill staffers as part of his team of advisors.
CDRH says it intends to extend the compliance dates for the unique device identification system requirements for low-risk medical devices (certain Cla...
Abbott begins a Class 1 recall of its Absorb Bioresorbable Vascular Scaffold system, a temporary scaffold indicated for improving coronary luminal dia...
A just-completed FDA inspection of Lupin Ltd.s Madhya Pradesh, India manufacturing facility results in a six-observation Form 483 related to GMP devia...
OncBioMune Pharmaceuticals submits to FDA a Phase 2 clinical trial protocol for ProscaVax, a novel therapeutic cancer vaccine for early stage prostate...
FDA clears a GenePOC 510(k) for its GBS LB assay and its revogene instrument, a molecular diagnostic for identifying antepartum Group B Streptococcus ...