This section highlights FDA-related milestones and regulatory updates for drugs developed by Applied DNA Sciences (APDN).
Over the past two years, Applied DNA Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LinearDNA and TR8™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LinearDNA - FDA Regulatory Timeline and Events
LinearDNA is a drug developed by Applied DNA Sciences for the following indication: COVID-19 Vaccine Candidate in Felines.
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:
- LinearDNA
- Announced Date:
- July 29, 2024
- Indication:
- COVID-19 Vaccine Candidate in Felines
Announcement
Applied DNA Sciences, Inc. a leader in PCR-based DNA technologies, will present a poster at the 4th Annual mRNA-based Therapeutics Summit taking place July 29 - 31, 2024, in Boston.
AI Summary
Applied DNA Sciences, Inc., a leader in PCR-based DNA technologies, will showcase its innovative work at the 4th Annual mRNA-based Therapeutics Summit in Boston from July 29 to 31, 2024. The company is set to present a poster titled “Reduction of dsRNA Contamination in High-Yield mRNA Production” on Tuesday, July 30, during a session scheduled from 3:45 to 4:30 p.m. local time. The poster highlights the Linea™ IVT platform—a complete, enzymatic solution combining a DNA template from the Linea™ DNA platform with a next-generation RNA polymerase—to reduce unwanted double-stranded RNA (dsRNA) in mRNA production.
This breakthrough approach aims to simplify mRNA manufacturing workflows, increase production speed, and minimize purification costs while supporting the advancement of mRNA therapeutics, vaccines, and personalized treatments. The presentation underscores Applied DNA’s commitment to leveraging decades of PCR-based expertise to overcome industry challenges in mRNA synthesis.
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TR8™ PGx - FDA Regulatory Timeline and Events
TR8™ PGx is a drug developed by Applied DNA Sciences for the following indication: pharmacogenomics testing service.
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:
- TR8™ PGx
- Announced Date:
- April 1, 2025
- Indication:
- pharmacogenomics testing service
Announcement
Applied DNA Sciences, announced that Applied DNA Clinical Labs (ADCL), its wholly-owned clinical laboratory subsidiary, is repositioning its TR8™ PGx pharmacogenomics testing service to offer tailored subpanels for indication-specific use cases in addition to full panel testing.
AI Summary
Applied DNA Sciences announced that its subsidiary, Applied DNA Clinical Labs, is updating its TR8™ PGx pharmacogenomics testing service. The company is shifting its approach by introducing tailored subpanels that can be used for specific clinical indications. This new strategy goes beyond the full panel testing previously offered by TR8™ PGx, allowing healthcare providers to choose tests that match particular treatment needs.
The first tailored subpanel focuses on detecting DPYD gene variants, which affect the body’s ability to process common chemotherapy drugs like capecitabine and fluorouracil. The TR8™ PGx test already examines 120 genetic targets across over 33 genes, and these new subpanels are designed to further support personalized treatment plans in areas such as oncology, cardiology, and psychiatry. By simplifying test selection, Applied DNA Sciences aims to improve clinical decision-making and enhance patient care.
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