FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing...
Former FDA oncology drug leader Richard Pazdur says concerns surrounding a controversial fast-track drug review initiative under commissioner Marty Ma...
FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantiv...
FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.
Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli significantly improv...
Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscular atrophy.
CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.
Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are violating antitrust laws...
