FDA News

WESTMINSTER, Colo.--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the “Company”), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced the initiation of patient enrollment for the PREDICTT clinical trial (NCT07444645), a prospective study designed to evaluate its novel Pressure-Enabled Drug Delivery™ (PEDD™) approach in patients w...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in immuno-oncology, today announced that the Company will release its first quarter 2026 financial results before the market opens on Monday, May 11, 2026. Agenus plans to host a webcast in June, in conjunction with its Annual Meeting of Shareholders, to spotlight key strategic priorities, upcoming data milestones, and progress across the global botensilimab (BOT) and balstilimab (BAL) development program. About...

BETHESDA, Md.--(BUSINESS WIRE)--BrainScope appoints David Wingate as VP of Sales, bringing 30+ years of medtech leadership to accelerate AI-enabled brain health adoption....

SANTA MONICA, Calif.--(BUSINESS WIRE)--mBIOTA Labs, an emerging medical food company revolutionizing medical nutrition for the management of gastrointestinal (GI) conditions, announced today that two abstracts featuring mBIOTA Elemental™ Diet are being presented at Digestive Disease Week 2026 in Chicago, Illinois. These abstracts demonstrate the clear effectiveness of mBIOTA Elemental as a therapeutic tool for patients living with Irritable Bowel Syndrome (IBS) and explore the mechanism by whic...

PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved LANGLARA™ (insulin glargine-aldy), as a biosimilar to Lantus® (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA has determined that LANGLARA is interchangeable with the reference drug,...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals Announces Primary Endpoint Met in VISTAS Study of Volixibat in Patients with Primary Sclerosing Cholangitis...

NEWTON, Mass.--(BUSINESS WIRE)--Satellite Biosciences, Inc. (Satellite Bio), a biotechnology company developing off-the-shelf liver therapies designed to restore liver function in patients with severe liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for SB-101 for the treatment of urea cycle disorders (UCDs). UCDs are a class of devastating conditions in which serious or life-threatening manifestations, such as...

ACTON, Mass.--(BUSINESS WIRE)--Insulet Initiates EVOLVE Pivotal Study to Advance Fully Closed-Loop Automated Insulin Delivery System for Type 2 Diabetes...

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode, a leader in multiplex molecular diagnostic solutions, today announced a significant enhancement to its BioCode® Respiratory Pathogen Panel (RPP) workflow with the addition of nucleic acid extraction claims for the widely used Thermo Fisher Scientific KingFisher™ Flex platform. This expansion provides clinical laboratories running BioCode® RPP with greater workflow flexibility and optimized sample processing capabilities. This enhanceme...

CHICAGO--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue. The data were presented at the 106th American Association for Thoracic Surgery Annual Meeting. As evidence increasingly supports treating patients earlier in the valve disease pathway, the need for durable valve solutions continues to grow. The COMMENCE trial provides prospectiv...