Federal Register notice: FDA makes available a final guidance entitled Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for Treatment.
FDA places a clinical hold on an Abeona Therapeutics planned Phase 3 clinical trial for EB-101 until it submits additional data points on transport st...
Researchers say oncologists can move quickly when FDA issues new safety information on therapies approved under accelerated approval programs.
FDA releases its latest batch of Warning Letters that includes one medical product company Nutra Solutions USA.
FDA approves Bavarian Nordics Jynneos smallpox and moneypox vaccine.
Federal Register notice: FDA makes available a draft guidance entitled Patient Engagement in the Design and Conduct of Medical Device Clinical Investi...
FDA issues a final guidance entitled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.
FDA approves Medtronics Evolut Pro+ Transcatheter Aortic Valve Replacement System.