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 releases the FDA-483 with five inspection observations issued following an inspection at the AveXis control testing laboratory.
CBER releases its summary deviations report for FY 2018 covering biological products and HCT/Ps.
An FDA advisory committee has voted 16-2 to recommend approval for Gilead Sciences HIV drug Descovy for pre-exposure prophylaxis (PrEP) in men and tra...