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FDA regulatory experts warn that the agencys user fee programs could be in jeopardy based on sweeping layoffs and political indiff...[ Price : $8.95]
Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use di...[ Price : $8.95]
FDA grants Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic...[ Price : $8.95]
A Senate HELP Committee postpones a hearing tentatively planned for 4/10 because HHS secretary Robert F. Kennedy, Jr. reportedly c...[ Price : $8.95]
Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for tr...[ Price : $8.95]
FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include p...[ Price : $8.95]
Former CDRH director Jeff Shuren says recent staff cuts at CDRH will likely lead to longer review times.[ Price : $8.95]
FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related d...