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Nasus Pharma (NSRX) FDA Approvals

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Nasus Pharma's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Nasus Pharma (NSRX). Over the past two years, Nasus Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NS002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

NS002 FDA Regulatory Events

NS002 is a drug developed by Nasus Pharma for the following indication: treatment of anaphylaxis. 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.

Nasus Pharma FDA Events - Frequently Asked Questions

As of now, Nasus Pharma (NSRX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Nasus Pharma (NSRX) has reported FDA regulatory activity for NS002.

The most recent FDA-related event for Nasus Pharma occurred on November 10, 2026, involving NS002. The update was categorized as "Abstract," with the company reporting: "Nasus Pharma Ltd. announced that abstracts supporting NS002, its investigational intranasal epinephrine powder for the treatment of anaphylaxis, have been accepted for presentation at the upcoming the American College of Allergy, Asthma & Immunology (“ACAAI”) 2026 Annual Scientific Meeting, to be held in Phoenix, AZ November 12-16, 2026."

Currently, Nasus Pharma has one therapy (NS002) targeting the following condition: treatment of anaphylaxis.

  • 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

FDA progress for NYSEAMERICAN:NSRX last updated on 11/10/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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