FDA issues two documents with information on its work involving regenerative medicine therapies.
Attorney Ethan Townsend says a recent Supreme Court decision will change the landscape and introduce new uncertainty into companies use of the impossi...
FDA accepts for priority review an Amarin supplemental NDA for Vascepa (icosapent ethyl) capsules, indicated to reduce residual cardiovascular risk in...
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.