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TFF Pharmaceuticals (TFFP) FDA Events

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FDA Events for TFF Pharmaceuticals (TFFP)

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

TFF Pharmaceuticals' Drugs in FDA Review

Tacrolimus Inhalation Powder - FDA Regulatory Timeline and Events

Tacrolimus Inhalation Powder is a drug developed by TFF Pharmaceuticals for the following indication: Lung transplant. 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.

TFF-dry powder HA - FDA Regulatory Timeline and Events

TFF-dry powder HA is a drug developed by TFF Pharmaceuticals for the following indication: Bivalent Universal Influenza Vaccine. 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.

TFF Pharmaceuticals FDA Events - Frequently Asked Questions

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

In the past two years, TFF Pharmaceuticals (TFFP) has reported FDA regulatory activity for the following drugs: Tacrolimus Inhalation Powder and TFF-dry powder HA.

The most recent FDA-related event for TFF Pharmaceuticals occurred on September 10, 2024, involving TFF-dry powder HA. The update was categorized as "Positive Data," with the company reporting: "TFF Pharmaceuticals, announces positive preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses."

Current therapies from TFF Pharmaceuticals in review with the FDA target conditions such as:

  • Lung transplant - Tacrolimus Inhalation Powder
  • Bivalent Universal Influenza Vaccine - TFF-dry powder HA

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