FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitted that the agency ha...
The Medical Device Innovation Consortium releases a new framework that outlines a systematic approach for patient-focused clinical trial designs.
Twenty-one state attorneys general urge FDA to approve over-the-counter birth control pills.
FDA clears an Exactech 510(k) for its TriVerse primary knee system.
FDA and academic researchers present a framework to include transgender people in clinical trials.
FDA issues a safety alert warning parents and caregivers not to use infant head shaping pillows intended to change an infants head shape or symmetry. ...
FDAs Pharmaceutical Science and Clinical Pharmacology Advisory Committee unanimously votes to recommend that CDER move forward with developing and imp...
FDA commissioner Robert Califf says FDA and its state and federal partners have made great progress in oversight of drug compounding, but there are st...
