US FDA Archives - Page 35 of 67 - Express Pharma

FDA publishes temporary guidance on manufacturing, supply chain, product inspections during COVID-19

US FDA declines approval for Gilead’s rheumatoid arthritis drug, Filgotinib

US FDA publishes compliance policy for quantity of samples retained for BA and BE studies

US FDA approves Enspryng from Genentech for neuromyelitis optica spectrum disorder

Lupin presents Phase 3 data for Solosec in female patients with trichomoniasis

US FDA approves Viltepso injection for treatment of Duchenne muscular dystrophy mutation

American Gene Technologies gets US FDA nod for Phase 1 clinical trial of potential HIV cure

Lupin launches Zileuton extended-release tablets

Roche gets US FDA approval for Evrysdi to treat spinal muscular atrophy

Gilead seeks full approval for remdesivir from US FDA for COVID-19 treatment