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FDA approves a Merck supplemental NDA for Keytruda (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, ...[ Price : $8.95]
FDA releases a draft guidance on Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment that is inte...[ Price : $8.95]
Stakeholders suggest improvements to an FDA draft guidance on using real-world evidence in medical device regulatory decisions.[ Price : $8.95]
FDA says Viracor-IBT Laboratories is selling unapproved Zika tests.[ Price : $8.95]
Stakeholders air concerns about an FDA draft guidance on UDI label components.[ Price : $8.95]
Federal Register Notice: FDA and CMS announce their intention to fully implement their joint parallel review pilot program.[ Price : $8.95]
FDA urges the public and industry insiders to report regulatory misconduct against medical device manufacturers or individuals mar...[ Price : $8.95]
FDA places a clinical hold on an Inovio Pharmaceuticals proposed phase 3 clinical program for VGX-3100, requesting additional data...