FDA Action Calendar

The Docket

A PDUFA calendar of upcoming FDA action dates, plus advisory committee meetings as they're scheduled — curated from sponsor disclosures and SEC 8-K filings. Filter by designation, indication, sponsor, or search.

MAR 22 2026 · CRL · 59 days ago

Crescent Genomics CRGX — CRG-09

for sickle cell disease

BLA · Priority Review · Breakthrough · Orphan · RMAT

CRL citing CMC observations from the Memphis manufacturing facility; sponsor planning Q4 2026 resubmission. Efficacy and safety were not flagged.

3 sources →

APR 15 2026 · APPROVED · 35 days ago

Astra Neurotherapeutics ASNT — ATX-911 (Verigan)

for early-onset Alzheimer's disease

BLA · Standard Review

Approved with boxed warning for ARIA-E and a REMS program; restricted to APOE ε4 non-homozygotes.

3 sources →

JUN 15 2026 · UPCOMING · 26 days

Northlake Therapeutics NLTX — INM-755

for epidermolysis bullosa simplex

BLA · Priority Review · Breakthrough · Orphan

Accepted OCT 16 2025. PDUFA: JUN 15 2026.

1 source →

JUL 20 2026 · EXTENDED · 61 days

Vela Medicines VELA — VEL-104

for HER2-positive metastatic gastric cancer

sBLA · Priority Review

Originally APR 20 2026; extended to JUL 20 2026 (Major Amendment, announced DEC 4 2025).

2 sources →

AUG 15 2026 · UPCOMING · 87 days

Harper Biopharm HBPM — HBP-201

for primary biliary cholangitis

NDA · Standard Review · Fast Track

Accepted NOV 15 2025. PDUFA: AUG 15 2026.

2 sources →

SEP 15 2026 · UPCOMING · 118 days

Solstice Bio SOLB — SB-208

for resistant hypertension

NDA · Standard Review

Accepted DEC 15 2025. PDUFA: SEP 15 2026.

1 source →