This section highlights FDA-related milestones and regulatory updates for drugs developed by Cerus (CERS).
Over the past two years, Cerus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INT200 and INTERCEPT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
INT200 - FDA Regulatory Timeline and Events
INT200 is a drug developed by Cerus for the following indication: for the INTERCEPT Blood System for platelets and plasma.
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:
- INT200
- Announced Date:
- May 28, 2025
- Indication:
- for the INTERCEPT Blood System for platelets and plasma
Announcement
Cerus Corporation announced two in-country regulatory approvals for INT200, one by the French National Agency for Medicines and Health Product Safety (ANSM) and the other by the Swiss Agency for Therapeutic Products (Swissmedic).
AI Summary
Cerus Corporation announced two important regulatory approvals for its INT200 device. The French National Agency for Medicines and Health Product Safety (ANSM) and the Swiss Agency for Therapeutic Products (Swissmedic) both approved the next-generation, LED-based illumination device. This achievement follows the recent CE Mark authorization and highlights the device’s strong safety and performance profile in Europe.
Designed to improve day-to-day operations in blood centers, the new INT200 offers a vertical configuration that saves bench space while enhancing workflow and ergonomics. It also features touch screen navigation, intuitive software, updated tray design, intelligent scanning, and custom reporting. In France and Switzerland, where treatment of platelet components with the INTERCEPT Blood System has been common practice since 2018 and 2011 respectively, these approvals validate Cerus’ innovation in improving blood supply safety.
Read Announcement- Drug:
- INT200
- Announced Date:
- March 5, 2025
- Indication:
- for the INTERCEPT Blood System for platelets and plasma
Announcement
Cerus Corporation announced the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood System for platelets and plasma under the European Union (EU) Medical Device Regulation (MDR).
AI Summary
Cerus Corporation announced that its next-generation LED-based illumination device, the INT200, has received CE mark approval under the EU Medical Device Regulation (MDR). This approval enables the company to commercially market the INT200 throughout the European Union and in other regions that accept the CE mark. Designed for the INTERCEPT Blood System for platelets and plasma, the INT200 offers enhanced user experience with its improved physical design and novel software interface, while remaining compatible with existing processing sets. Cerus believes this innovative platform will drive future growth and help expand geographic reach for the INTERCEPT business. The new device builds on the company’s commitment to providing reliable pathogen inactivation, ensuring blood centers receive a robust and efficient tool as they transition to the new platform. This milestone positions Cerus for continued leadership in advancing global transfusion safety.
Read Announcement
INTERCEPT Blood System - FDA Regulatory Timeline and Events
INTERCEPT Blood System is a drug developed by Cerus for the following indication: for platelets, plasma, IFC, and red blood cells.
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:
- INTERCEPT Blood System
- Announced Date:
- July 2, 2025
- Indication:
- for platelets, plasma, IFC, and red blood cells
Announcement
Cerus Corporation announced a European regulatory update on the INTERCEPT RBC program.
AI Summary
Cerus Corporation announced a major European regulatory update on its INTERCEPT Red Blood Cells (RBC) program. The company’s Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission. This review incorporated positive results from the U.S. Phase 3 ReCePI clinical trial, expanding the submission to cover all patient indications for RBC transfusion.
Following this milestone, TÜV-SÜD transferred the clinical module information to the State Institute for Drug Control (SÚKL) in the Czech Republic for consultation. With SÚKL set to review the active pharmaceutical ingredient (API) module next, Cerus is moving ahead in the multi-step process. The company looks forward to working with both TÜV-SÜD and SÚKL to finalize the enhanced CE Mark submission for its INTERCEPT RBC system.
Read Announcement- Drug:
- INTERCEPT Blood System
- Announced Date:
- May 29, 2025
- Indication:
- for platelets, plasma, IFC, and red blood cells
Announcement
Cerus Corporation announced it will showcase the latest INTERCEPT Blood System clinical data at the 35th Regional International Society of Blood Transfusion (ISBT) Congress being held May 31 to June 4, 2025, in Milan.
AI Summary
Cerus Corporation announced it will present the latest INTERCEPT Blood System clinical data at the 35th Regional International Society of Blood Transfusion (ISBT) Congress in Milan, scheduled for May 31 to June 4, 2025. During this event, Cerus will share new findings from studies on various blood components, including platelets, plasma, and red blood cells.
One highlight of the presentations is the positive results from the Phase 3 ReCePI study in red blood cells, along with data on INTERCEPT-treated cold stored platelets and the effective inactivation of the California encephalitis virus. This data underscores the broad applicability and potential benefits of the INTERCEPT system in enhancing blood safety and transfusion efficacy. Attendees at the congress will have the opportunity to learn about these advancements and the system’s role in improving blood product management and patient outcomes.
Read Announcement
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