Market Intelligence
Real-time FDA regulatory updates for the bio-pharma sector.
Just Approved
BRIUMVI
TG THERAPEUTICS, INC
Recent Regulatory Decisions
View All LOSARTAN POTASSIUM Sep 26, 2014
LOSARTAN POTASSIUM
HIKMA
IMPLANON Jan 18, 2007
ETONOGESTREL
ORGANON
METHYLPHENIDATE HYDROCHLORIDE Jan 15, 2026
METHYLPHENIDATE HYDROCHLORIDE
MOUNTAIN
OSELTAMIVIR PHOSPHATE Jan 15, 2026
OSELTAMIVIR PHOSPHATE
AJANTA PHARMA LTD
OXALIPLATIN Jan 15, 2026
OXALIPLATIN
SHANDONG
Upcoming Milestones
Full Calendar 31 JAN
PDUFA: Anaphylm (Aquestive)
Decision on sublingual film for Anaphylaxis.
08 FEB
PDUFA: RGX-121 (Regenxbio)
Priority review for MPS II treatment.