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Zai Lab (ZLAB) FDA Events

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FDA Events for Zai Lab (ZLAB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Zai Lab (ZLAB). Over the past two years, Zai Lab has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Efgartigimod, KarXT, Repotrectinib, ZL-1102, ZL-1218, ZL-1310, and ZL-1503. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Zai Lab's Drugs in FDA Review

Efgartigimod Alfa Injection - FDA Regulatory Timeline and Events

Efgartigimod Alfa Injection is a drug developed by Zai Lab for the following indication: For the treatment of adult patients with generalized myasthenia gravis (gMG). 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.

KarXT (xanomeline-trospium) - FDA Regulatory Timeline and Events

KarXT (xanomeline-trospium) is a drug developed by Zai Lab for the following indication: Healthy Elderly Volunteers. 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.

Repotrectinib - FDA Regulatory Timeline and Events

Repotrectinib is a drug developed by Zai Lab for the following indication: NTRK Fusion-Positive Advanced Solid Tumors. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ZL-1102 - FDA Regulatory Timeline and Events

ZL-1102 is a drug developed by Zai Lab for the following indication: Mild-to-moderate chronic plaque psoriasis (CPP). 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.

ZL-1218 - FDA Regulatory Timeline and Events

ZL-1218 is a drug developed by Zai Lab for the following indication: For the Treatment of Advanced Solid Tumors. 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.

ZL-1310 - FDA Regulatory Timeline and Events

ZL-1310 is a drug developed by Zai Lab for the following indication: For DLL3+ Solid Tumors. 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.

ZL-1503 - FDA Regulatory Timeline and Events

ZL-1503 is a drug developed by Zai Lab for the following indication: For the Treatment of Atopic Dermatitis. 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.

ZL-6201 - FDA Regulatory Timeline and Events

ZL-6201 is a drug developed by Zai Lab for the following indication: For the treatment of sarcoma. 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.

Zai Lab FDA Events - Frequently Asked Questions

Yes, Zai Lab (ZLAB) has received FDA approval for Repotrectinib. This page tracks recent and historical FDA regulatory events related to Zai Lab's drug portfolio.

In the past two years, Zai Lab (ZLAB) has reported FDA regulatory activity for the following drugs: ZL-1310, Repotrectinib, ZL-1503, ZL-6201, KarXT (xanomeline-trospium), ZL-1218, Efgartigimod Alfa Injection and ZL-1102.

The most recent FDA-related event for Zai Lab occurred on June 13, 2025, involving ZL-1503. The update was categorized as "New Data," with the company reporting: "Zai Lab Limited announced new data from its preclinical study of ZL-1503, the Company's promising IL-13/IL-31R bispecific antibody, demonstrating its ability to simultaneously suppress the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis (AD)."

Current therapies from Zai Lab in review with the FDA target conditions such as:

  • For DLL3+ Solid Tumors - ZL-1310
  • NTRK Fusion-Positive Advanced Solid Tumors - Repotrectinib
  • For the Treatment of Atopic Dermatitis - ZL-1503
  • For the treatment of sarcoma - ZL-6201
  • Healthy Elderly Volunteers - KarXT (xanomeline-trospium)
  • For the Treatment of Advanced Solid Tumors - ZL-1218
  • For the treatment of adult patients with generalized myasthenia gravis (gMG). - Efgartigimod Alfa Injection
  • Mild-to-moderate chronic plaque psoriasis (CPP) - ZL-1102

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:ZLAB) was last updated on 7/11/2025 by MarketBeat.com Staff
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