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FDA accepts for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults.[ Price : $8.95]
Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.[ Price : $8.95]
A CDER study examines generic nasal spray distribution factors that could speed the development of generic sprays.[ Price : $8.95]
FDA clears a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating...[ Price : $8.95]
FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing ...[ Price : $8.95]
A lengthy online newsletter written by several Skadden attorneys explores possible new theories of cybersecurity False Claims Act ...[ Price : $8.95]
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.[ Price : $8.95]
The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management mat...