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Labcorp (LH) FDA Events

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FDA Events for Labcorp (LH)

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

Labcorp's Drugs in FDA Review

Mpox PCR Test - FDA Regulatory Timeline and Events

Mpox PCR Test is a drug developed by Labcorp for the following indication: to aid in the diagnosis of infection with non-variola Orthopoxvirus. 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.

nAbCyte - FDA Regulatory Timeline and Events

nAbCyte is a drug developed by Labcorp for the following indication: for treatment with BEQVEZ™. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

PGDx elio™ - FDA Regulatory Timeline and Events

PGDx elio™ is a drug developed by Labcorp for the following indication: For pan-solid tumor liquid biopsy test. 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.

Labcorp FDA Events - Frequently Asked Questions

Yes, Labcorp (LH) has received FDA approval for nAbCyte. This page tracks recent and historical FDA regulatory events related to Labcorp's drug portfolio.

In the past two years, Labcorp (LH) has reported FDA regulatory activity for the following drugs: PGDx elio™, nAbCyte and Mpox PCR Test.

The most recent FDA-related event for Labcorp occurred on April 23, 2025, involving PGDx elio™. The update was categorized as "Provided Update," with the company reporting: "Labcorp announced the expansion of its precision oncology portfolio with two solutions: Labcorp Plasma Detect for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients, and the availability of PGDx elio plasma focus Dx, the first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments."

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

  • For pan-solid tumor liquid biopsy test. - PGDx elio™
  • for treatment with BEQVEZ™ - nAbCyte
  • to aid in the diagnosis of infection with non-variola Orthopoxvirus - Mpox PCR Test

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 (NYSE:LH) was last updated on 7/10/2025 by MarketBeat.com Staff
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