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Jazz Pharmaceuticals (JAZZ) FDA Events

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FDA Events for Jazz Pharmaceuticals (JAZZ)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Jazz Pharmaceuticals (JAZZ). Over the past two years, Jazz Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Epidiolex, Suvecaltamide, Xywav, Zanidatamab, Zepzelca, and Ziihera. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Jazz Pharmaceuticals' Drugs in FDA Review

Epidiolex (cannabidiol) - FDA Regulatory Timeline and Events

Epidiolex (cannabidiol) is a drug developed by Jazz Pharmaceuticals for the following indication: Epilepsy with Myoclonic-Atonic Seizures (EMAS). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Suvecaltamide - FDA Regulatory Timeline and Events

Suvecaltamide is a drug developed by Jazz Pharmaceuticals for the following indication: For the potential treatment of moderate to severe essential tremor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Xywav - FDA Regulatory Timeline and Events

Xywav is a drug developed by Jazz Pharmaceuticals for the following indication: Idiopathic hypersomnia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Zanidatamab - FDA Regulatory Timeline and Events

Zanidatamab is a drug developed by Jazz Pharmaceuticals for the following indication: In HER2+/HR+ Metastatic Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Zepzelca (lurbinectedin) - FDA Regulatory Timeline and Events

Zepzelca (lurbinectedin) is a drug developed by Jazz Pharmaceuticals for the following indication: Relapsed Small Cell Lung Cancer (SCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Ziihera - FDA Regulatory Timeline and Events

Ziihera is a drug developed by Jazz Pharmaceuticals for the following indication: For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Jazz Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Jazz Pharmaceuticals (JAZZ) has reported FDA regulatory activity for the following drugs: Zanidatamab, Ziihera, Zepzelca (lurbinectedin), Epidiolex (cannabidiol), Xywav and Suvecaltamide.

The most recent FDA-related event for Jazz Pharmaceuticals occurred on July 1, 2025, involving Ziihera. The update was categorized as "Marketing authorization," with the company reporting: "Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.2"

Current therapies from Jazz Pharmaceuticals in review with the FDA target conditions such as:

  • In HER2+/HR+ Metastatic Breast Cancer - Zanidatamab
  • For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) - Ziihera
  • Relapsed Small Cell Lung Cancer (SCLC) - Zepzelca (lurbinectedin)
  • Epilepsy with Myoclonic-Atonic Seizures (EMAS) - Epidiolex (cannabidiol)
  • Idiopathic hypersomnia - Xywav
  • For the potential treatment of moderate to severe essential tremor - Suvecaltamide

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:JAZZ) was last updated on 7/10/2025 by MarketBeat.com Staff
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