FDA Events for Agilent Technologies (A)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Agilent Technologies (A).
Over the past two years, Agilent Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SK032. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SK032 - FDA Regulatory Timeline and Events
SK032 is a drug developed by Agilent Technologies for the following indication: For Use with Newly Approved TCR T-Cell Therapy.
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.
- Drug:
- SK032
- Announced Date:
- August 2, 2024
- Indication:
- For Use with Newly Approved TCR T-Cell Therapy
Announcement
Agilent Technologies Inc announced that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy.
AI Summary
Agilent Technologies Inc. recently received FDA approval for its MAGE-A4 IHC 1F9 pharmDx (SK032), a diagnostic tool designed to help identify patients with synovial sarcoma who may benefit from TECELRA® treatment. TECELRA®, also known as afamitresgene autoleucel or afami-cel, is a MAGE-A4-directed engineered T-cell receptor therapy developed to target cancers overexpressing the MAGE-A4 antigen.
The MAGE-A4 IHC 1F9 pharmDx assay uses immunohistochemistry to detect MAGE-A4 in formalin-fixed paraffin-embedded synovial sarcoma tissue. A positive result indicates that patients could be eligible for TECELRA® therapy, offering a new approach for individuals with advanced synovial sarcoma. This FDA approval underscores Agilent's role in advancing companion diagnostics that support innovative cancer treatments.
Read Announcement
Agilent Technologies FDA Events - Frequently Asked Questions
As of now, Agilent Technologies (A) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Agilent Technologies (A) has reported FDA regulatory activity for SK032.
The most recent FDA-related event for Agilent Technologies occurred on August 2, 2024, involving SK032. The update was categorized as "FDA Approval," with the company reporting: "Agilent Technologies Inc announced that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy. "
Currently, Agilent Technologies has one therapy (SK032) targeting the following condition: For Use with Newly Approved TCR T-Cell Therapy.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:A) was last updated on 7/11/2025 by MarketBeat.com Staff
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