FDA medical reviewers ask the Endocrinologic and Metabolic Diseases Advisory Committee to discuss efficacy and safety information on Amarins Vascepa.
FDA releases its latest batch of Warning Letters that includes MSM Nutraceuticals, Cadila Healthcare and Swabplus.
FDA principal deputy commissioner Lloyd Schiller says the agency is looking at changes to the Dietary Supplement Health and Education Act to enable it...
FDA places a Solid Biosciences Phase 1/2 trial of its SGT-001 Duchenne muscular dystrophy drug on clinical hold.
Federal Register notice: FDA submits to OMB an information collection extension for Format and Content Requirements for Over-the-Counter Drug Product ...
Start-up pharmacy Valisure makes a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for co...
Regenxbio files a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases.
FDA grants AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy images for diagnosing ...