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Castle Biosciences (CSTL) FDA Events

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FDA Events for Castle Biosciences (CSTL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Castle Biosciences (CSTL). Over the past two years, Castle Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DecisionDx-Melanoma, DecisionDx-SCC, and TSP-9. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Castle Biosciences' Drugs in FDA Review

DecisionDx-Melanoma - FDA Regulatory Timeline and Events

DecisionDx-Melanoma is a drug developed by Castle Biosciences for the following indication: Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity. 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.

DecisionDx-SCC - FDA Regulatory Timeline and Events

DecisionDx-SCC is a drug developed by Castle Biosciences for the following indication: High-risk cutaneous squamous cell carcinoma (SCC). 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.

TSP-9 - FDA Regulatory Timeline and Events

TSP-9 is a drug developed by Castle Biosciences for the following indication: In identifying high-risk NDBE patients. 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.

Castle Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Castle Biosciences (CSTL) has reported FDA regulatory activity for the following drugs: DecisionDx-Melanoma, DecisionDx-SCC and TSP-9.

The most recent FDA-related event for Castle Biosciences occurred on May 29, 2025, involving DecisionDx-Melanoma. The update was categorized as "Presentation," with the company reporting: "Castle Biosciences, announced that it will present novel research aimed at enhancing the clinical management of patients with cutaneous melanoma (CM) and uveal melanoma (UM) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30-June 3, 2025, in Chicago."

Current therapies from Castle Biosciences in review with the FDA target conditions such as:

  • Cutaneous melanoma metastasis or recurrence and Sentinel lymph node (SLN) positivity - DecisionDx-Melanoma
  • High-risk cutaneous squamous cell carcinoma (SCC) - DecisionDx-SCC
  • In identifying high-risk NDBE patients - TSP-9

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