An 11th Circuit Appeals Court panel upholds a Florida district court decision in favor of FDA in a suit against US Stem Cell Clinic.
FDA says healthcare providers should no longer implant the Medtronic Heartware Ventricular Assist Device system that the company is no longer selling ...
FDA posts a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations.
FDA accepts for review a Liquidia NDA resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension.
A Pew Charitable Trusts report details adverse events reported by patients using unapproved stem cell and regenerative medicine interventions and call...
The Massachusetts federal court grants summary judgment to GlaxoSmithKline and dismisses as preempted a suit claiming the company failed to warn pregn...
CDRH ASCA team member Angela DeMarco says the ASCA pilot program is on schedule with 53 test labs accredited.
FDA grants a de novo marketing authorization request to Cognoa for its Cognoa ASD Diagnosis Aid to help diagnose autism spectrum disorder.