Free Trial

TC Biopharm (TCBP) FDA Events

TC Biopharm logo
$0.68 -0.86 (-55.78%)
Closing price 03/21/2025
Extended Trading
$0.68 0.00 (0.00%)
As of 03/21/2025 08:00 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for TC Biopharm (TCBP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by TC Biopharm (TCBP). Over the past two years, TC Biopharm has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TCB, TCB008, and TCB-008. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

TC Biopharm's Drugs in FDA Review

TCB 008 - FDA Regulatory Timeline and Events

TCB 008 is a drug developed by TC Biopharm for the following indication: For Treatment of Monkey Pox. 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.

TCB008 - FDA Regulatory Timeline and Events

TCB008 is a drug developed by TC Biopharm for the following indication: In patients with AML or MDS/AML, with either refractory or relapsed disease. 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.

TCB-008 - FDA Regulatory Timeline and Events

TCB-008 is a drug developed by TC Biopharm for the following indication: Unmodified expanded gamma delta T cell Lymphocytes. 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.

TC Biopharm FDA Events - Frequently Asked Questions

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

In the past two years, TC Biopharm (TCBP) has reported FDA regulatory activity for the following drugs: TCB008, TCB 008 and TCB-008.

The most recent FDA-related event for TC Biopharm occurred on June 11, 2025, involving TCB008. The update was categorized as "Provided Update," with the company reporting: "TC BioPharm announced the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008."

Current therapies from TC Biopharm in review with the FDA target conditions such as:

  • In patients with AML or MDS/AML, with either refractory or relapsed disease. - TCB008
  • For Treatment of Monkey Pox - TCB 008
  • Unmodified expanded gamma delta T cell Lymphocytes - TCB-008

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:TCBP) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners