FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.
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 releases the form FDA-483 with eight observations from an inspection at Indias Shilpa Medicare drug manufacturing facility.
The ranking member of a House Select Committee on competition with China writes to three Chinese drug companies asking for detailed information on the...
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.
