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Traws Pharma (TRAW) FDA Events

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FDA Events for Traws Pharma (TRAW)

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

Traws Pharma's Drugs in FDA Review

ratutrelvir - FDA Regulatory Timeline and Events

ratutrelvir is a drug developed by Traws Pharma for the following indication: An Oral Mpro Inhibitor. 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.

rigosertib - FDA Regulatory Timeline and Events

rigosertib is a drug developed by Traws Pharma for the following indication: In RDEB SCC Patients Treated with Legacy Oncology Drug Rigosertib. 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.

tivoxavir - FDA Regulatory Timeline and Events

tivoxavir is a drug developed by Traws Pharma for the following indication: for Flu Candidate. 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.

Traws Pharma FDA Events - Frequently Asked Questions

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

In the past two years, Traws Pharma (TRAW) has reported FDA regulatory activity for the following drugs: tivoxavir, ratutrelvir and rigosertib.

The most recent FDA-related event for Traws Pharma occurred on June 30, 2025, involving tivoxavir. The update was categorized as "Regulatory Update," with the company reporting: "Traws Pharma, Inc. announced multiple regulatory submissions related to its antiviral pipeline."

Current therapies from Traws Pharma in review with the FDA target conditions such as:

  • for Flu Candidate - tivoxavir
  • An Oral Mpro Inhibitor - ratutrelvir
  • In RDEB SCC Patients Treated with Legacy Oncology Drug Rigosertib - rigosertib

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:TRAW) was last updated on 7/9/2025 by MarketBeat.com Staff
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