The Supreme Court refuses to set aside an appeals court ruling siding with GlaxoSmithKline in a Paxil failure-to-warn case.
FDA grants Bayer a Breakthrough Therapy Designation for Aliqopa (copanlisib) for treating adult patients with relapsed marginal zone lymphoma who have...
FDA clears a Medtronic 510(k) for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing.
FDA approves a Celgene supplemental NDA for Revlimid (lenalidomide) in combination with rituximab for treating adult patients with previously treated ...
FDA releases its latest batch of Warning Letters that includes one medical product company AMMD Labs.
Researchers say confirmatory trials for only 20% of cancer drug indications approved via accelerated approval demonstrated improvement in overall pati...
Two FDAers set a context and background for agency efforts to develop a drug benefit-risk assessment framework and process as part of a public meeting...
Four Republican senators call on FDA to expand its HIV/AIDS parallel track to other major diseases to speed drugs to patients.