Veppanu (vepdegestrant)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- vepdegestrant
- Company
- Rigel Pharms
- Status
- Approved
- FDA approval
- Fri 01 May 2026
- Designations
- New molecular entity
- Application
- NDA219835
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 05 Jun 2026🇺🇸 PDUFA datecompany-announced
VEPPANU: PDUFA target action date (ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of end)
Arvinas, Inc. (ARVN); vepdegestrant; status: met; "FDA approval was received in advance of FDA-assigned Prescription Drug User Fee Act (“PDUFA”) date of June 5, 2026."; filed 2026-05-01 · source
Fri 01 May 2026🇺🇸 FDA approval
FDA approves Veppanu (vepdegestrant), a new medicine
Rigel Pharms; NDA219835; New molecular entity; tablet · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.