Jazz Pharmaceuticals plc
4 products tracked · names used in filings: Jazz Pharmaceuticals plc, Jazz Pharmaceuticals Ireland Limited
Upcoming milestones
Epidiolex: PDUFA target action date (oral cannabidiol capsule formulation)
Jazz Pharmaceuticals plc (JAZZ); cannabidiol; NDA; status: set; "…The PDUFA target action date for our New Drug Application (NDA) for the oral cannabidiol capsule formulation is April 16, 2027."; filed 2026-11-02 · source
Recent milestones
Ziihera: PDUFA target action date (first-line HER2+ gastroesophageal adenocarcinoma (GEA))
Jazz Pharmaceuticals plc (JAZZ); zanidatamab-hrii; sBLA; status: set; "Food and Drug Administration (FDA) granted Priority Review and set Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026 for supplemental Biologics License Application (sBLA) for zanidatamab containing combinations in first-line (1L) gastroesophageal adenocarcinoma (GEA)."; filed 2026-08-03 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Ziihera zanidatamab | Authorised | 2025-06-27 |
| 🇪🇺 | Enrylaze crisantaspase | Authorised | 2023-09-15 |
| 🇪🇺 | Epidyolex cannabidiol | Authorised | 2019-09-19 |
| 🇪🇺 | Vyxeos liposomal (previously Vyxeos) daunorubicin;cytarabine | Authorised | 2018-08-23 |
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.