FDA Events for Maravai LifeSciences (MRVI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Maravai LifeSciences (MRVI).
Over the past two years, Maravai LifeSciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AccuRes™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AccuRes™ - FDA Regulatory Timeline and Events
AccuRes™ is a drug developed by Maravai LifeSciences for the following indication: For the target host cell line as opposed to off-target DNA.
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:
- AccuRes™
- Announced Date:
- August 28, 2024
- Indication:
- For the target host cell line as opposed to off-target DNA
Announcement
Cygnus Technologies (Cygnus), TriLink BioTechnologies (TriLink®), both part of Maravai LifeSciences (NASDAQ:MRVI) have collaborated to launch Cygnus' AccuRes™ Host Cell DNA Quantification Kits.
AI Summary
Cygnus Technologies has teamed up with TriLink BioTechnologies, both part of Maravai LifeSciences, to launch the new AccuRes™ Host Cell DNA Quantification Kits. These kits are designed to recover, amplify, and accurately measure residual host cell DNA in biotherapeutic manufacturing. By using advanced probe-based technology, the assay offers unmatched sensitivity—with a detection limit of 0.6 fg/µL—and specificity by targeting the intended host cell lines. The all-in-one kit includes reagents for DNA extraction, a proprietary PCR master mix with TriLink’s patented CleanAmp® dNTPs, and is compatible with any qPCR instrument that detects FAM signals, eliminating extra costs for additional equipment. This innovative solution aims to help produce safer and more stable vaccines and therapies by ensuring biotherapeutics meet stringent regulatory standards for residual DNA levels.
Read Announcement
Maravai LifeSciences FDA Events - Frequently Asked Questions
As of now, Maravai LifeSciences (MRVI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Maravai LifeSciences (MRVI) has reported FDA regulatory activity for AccuRes™.
The most recent FDA-related event for Maravai LifeSciences occurred on August 28, 2024, involving AccuRes™. The update was categorized as "Provided Update," with the company reporting: "Cygnus Technologies (Cygnus), TriLink BioTechnologies (TriLink®), both part of Maravai LifeSciences (NASDAQ:MRVI) have collaborated to launch Cygnus' AccuRes™ Host Cell DNA Quantification Kits."
Currently, Maravai LifeSciences has one therapy (AccuRes™) targeting the following condition: For the target host cell line as opposed to off-target DNA.
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 (NASDAQ:MRVI) was last updated on 7/10/2025 by MarketBeat.com Staff
