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Atossa Genetics (ATOS) FDA Approvals

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Atossa Genetics' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Atossa Genetics (ATOS). Over the past two years, Atossa Genetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Z-endoxifen, endoxifen-Z, Endoxifen, and EVANGELINE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Z-endoxifen FDA Regulatory Timeline and Events

Z-endoxifen is a drug developed by Atossa Genetics for the following indication: Breast cancer in the neoadjuvant (prior to surgery) setting. 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.

Endoxifen-Z FDA Regulatory Timeline and Events

Endoxifen-Z is a drug developed by Atossa Genetics for the following indication: for 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.

Endoxifen FDA Regulatory Timeline and Events

Endoxifen is a drug developed by Atossa Genetics for the following indication: 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.

EVANGELINE FDA Regulatory Events

EVANGELINE is a drug developed by Atossa Genetics for the following indication: for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative 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.

Atossa Genetics FDA Events - Frequently Asked Questions

In the past two years, Atossa Genetics (ATOS) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Atossa Genetics (ATOS) has reported FDA regulatory activity for the following drugs: endoxifen-Z, Z-endoxifen, Endoxifen and EVANGELINE.

The most recent FDA-related event for Atossa Genetics occurred on May 4, 2026, involving Z-endoxifen. The update was categorized as "Designation Grant," with the company reporting: "Atossa Therapeutics, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Rare Pediatric Disease ("RPD") designation to (Z)-endoxifen for the treatment of McCune-Albright Syndrome ("MAS") in females."

Current therapies from Atossa Genetics in review with the FDA target conditions such as:

  • for Breast Cancer - endoxifen-Z
  • Breast cancer in the neoadjuvant (prior to surgery) setting - Z-endoxifen
  • Breast Cancer - Endoxifen
  • for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer. - EVANGELINE

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

FDA progress for NASDAQ:ATOS last updated on 5/4/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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