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Alpha Tau Medical (DRTS) FDA Events

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Closing price 07/10/2025 03:59 PM Eastern
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FDA Events for Alpha Tau Medical (DRTS)

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

Alpha DaRT - FDA Regulatory Timeline and Events

Alpha DaRT is a drug developed by Alpha Tau Medical for the following indication: Prostate 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.

Alpha Tau Medical FDA Events - Frequently Asked Questions

As of now, Alpha Tau Medical (DRTS) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Alpha Tau Medical (DRTS) has reported FDA regulatory activity for Alpha DaRT.

The most recent FDA-related event for Alpha Tau Medical occurred on April 2, 2025, involving Alpha DaRT. The update was categorized as "FDA Approval," with the company reporting: "Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology."

Currently, Alpha Tau Medical has one therapy (Alpha DaRT) targeting the following condition: Prostate cancer.

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