FDA says it is planning an 11/7 public meeting to seek input on opportunities and priorities for CDERs Office of New Drugs.
FDA issues Kala Pharmaceuticals a complete response letter on its NDA for KPI-121 (loteprednol etabonate) for dry eye disease signs and symptoms.
A new FDA Impact Story discusses new research undertaken to help would-be generic topical dermatological drug product developers demonstrate bioequiva...
FDA accepts for review an Ortho Dermatologics NDA for tazarotene 0.045% lotion for treating moderate to severe acne.
Amarin says FDA likely will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules after reveal...
FDA gives Endologix authorization to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealin...
Federal Register notice: FDA makes available a draft guidance on Fabry Disease drug development.
Evoke Pharma says it will resubmit its NDA for Gimoti nasal spray to FDA by the end of this year.