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.
Researchers say that atrial fibrillation patients who use smartwatches or other wearable devices to manage their condition make greater follow-up use ...
FDA says 97 medical device manufacturers may be affected by sterility issues at the now-closed Steril Milano ethylene oxide sterilization facilities i...
FDA approves a Scynexis NDA for Brexafemme (ibrexafungerp) tablets for oral use in patients with a vaginal yeast infection.
The Council for Responsible Nutrition says FDA should revert to its prior policy allowing NAC to be sold as a dietary supplement.