FDA clears a Life Spine 510(k) for the Prolift Expandable Spacer System.
FDA says Allergan has agreed to remove from the market certain of its textured breast implant products and tissue expanders due to an association with...
FDA solicits comments on its publication of a glossary of terms part of the BEST Resource Taxonomy.
FDA cancels a 7/31 advisory committee meeting intended to review an Intra-Cellular Therapies NDA for lumateperone tosylate capsules for treating schiz...
Loyola Law School professor Adam Zimmerman says a recent Supreme Court decision in an impossibility preemption case highlights splits among liberal an...
Maquet/Datascope recalls all Intra-Aortic Balloon Pumps (IABP) due to reports about its batteries failing to hold a charge.
FDA approves a Samsung Bioepis BLA for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbotts Humira.
Federal Register notice: FDA submits to OMB an information collection extension for Clinical Laboratory Improvement Amendments waivers.