#FDA Approval

Articles (6)

• 🇺🇸 FDA grants fast track status to Cocrystal’s norovirus drug — 02/04/2026 [USA] Related: #Pharmaceutical Development
• 🇺🇸 FDA accepts BioXcel Therapeutics application for IGALMI in at-home agitation treatment — 01/04/2026 [USA] Related: #Mental Health, #Pharmaceuticals
• 🇺🇸 Savara receives FDA priority review for rare lung disease drug — 13/03/2026 [USA] Related: #Rare Diseases
• 🇺🇸 FDA approves leucovorin as first drug for rare genetic disorder, after touting it as autism treatment — 10/03/2026 [USA]

  The move comes months after the Trump administration touted leucovorin as a potential therapy for a broader group of patients with autism symptoms.

  Related: #Rare Disease, #Drug Repurposing
• 🇺🇸 FDA approves Wellcovorin for ultra-rare disease. The Trump admin touted it as a treatment for autism — 10/03/2026 [USA]

  The Food and Drug Administration (FDA) on Tuesday granted expanded approval to Wellcovorin for the ultra-rare disease cerebral folate deficiency (CFD) in both children and adults, the same prescriptio...

  Related: #Medical Controversy
• 🇺🇸 FDA approves Sotyktu for active psoriatic arthritis treatment — 07/03/2026 [USA] Related: #Medical Treatment