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BeOne Medicines (ONC) FDA Events

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FDA Events for BeOne Medicines (ONC)

This section highlights FDA-related milestones and regulatory updates for drugs developed by BeOne Medicines (ONC). Over the past two years, BeOne Medicines has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BRUKINSA® and Tislelizumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

BeOne Medicines' Drugs in FDA Review

BRUKINSA® (zanubrutinib) - FDA Regulatory Timeline and Events

BRUKINSA® (zanubrutinib) is a drug developed by BeOne Medicines for the following indication: Inhibitor of Bruton's tyrosine kinase. 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.

Tislelizumab - FDA Regulatory Timeline and Events

Tislelizumab is a drug developed by BeOne Medicines for the following indication: Recurrent or Metastatic Nasopharyngeal 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.

BeOne Medicines FDA Events - Frequently Asked Questions

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

In the past two years, BeOne Medicines (ONC) has reported FDA regulatory activity for the following drugs: Tislelizumab and BRUKINSA® (zanubrutinib).

The most recent FDA-related event for BeOne Medicines occurred on July 10, 2025, involving Tislelizumab. The update was categorized as "Approved," with the company reporting: "BeOne Medicines Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy."

Current therapies from BeOne Medicines in review with the FDA target conditions such as:

  • Recurrent or Metastatic Nasopharyngeal Cancer - Tislelizumab
  • Inhibitor of Bruton's tyrosine kinase - BRUKINSA® (zanubrutinib)

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:ONC) was last updated on 7/10/2025 by MarketBeat.com Staff
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