PDUFA Dates: March 2026

8 FDA target action dates in March 2026. Each PDUFA date is the FDA's deadline to complete review of a drug application.

Mix: 3 NDAs, 1 sNDA, 1 BLA, 3 unspecified. Therapeutic areas: immunology, metabolic, ophthalmology.

ANAPTYSBIO, INC ANAB

Mar 1, 2026

139 days ago

Aldeyra Therapeutics, Inc. ALDX CRL

Reproxalap

Dry eye disease Ophthalmology

NDA

Mar 16, 2026

124 days ago

Johnson & Johnson JNJ APPROVED

ICOTYDE (icotrokinra)

Moderate-to-severe plaque psoriasis in adults and adolescents 12+ Immunology

NDA

Mar 18, 2026

122 days ago

GSK plc GSK

Lynavoy (linerixibat)

Cholestatic pruritus in primary biliary cholangitis (PBC)

NDA Orphan Drug

Mar 19, 2026

121 days ago

Rhythm Pharmaceuticals, Inc. RYTM APPROVED

IMCIVREE (setmelanotide)

Acquired hypothalamic obesity Metabolic

sNDA

Mar 20, 2026

120 days ago

GSK plc GSK, GLAXF

Mar 24, 2026

116 days ago

Rocket Pharmaceuticals, Inc. RCKT APPROVED

Kresladi (marnetegragene autotemcel)

Leukocyte Adhesion Deficiency Type 1 (LAD-I)

BLA

Mar 28, 2026

112 days ago

Lantheus Holdings, Inc. LNTH

Mar 29, 2026

111 days ago

All PDUFA Months