FDA News

SINGAPORE--(BUSINESS WIRE)--Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stabi...

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026. Fol...

WOODBRIDGE, Conn.--(BUSINESS WIRE)--Cure Rare Disease (CRD) announced it has been awarded a $7.4 million grant from the California Institute for Regenerative Medicine (CIRM) to advance the development of a novel gene therapy for Limb-Girdle Muscular Dystrophy Type 2i/R9 (LGMD2i/R9), a progressive neuromuscular disorder with limited treatment options. Cure Rare Disease launched its LGMD2i/R9 program to develop a therapeutic solution for patients suffering from this rare condition. The program, C...

SAN DIEGO--(BUSINESS WIRE)--SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, has published a peer-reviewed article in the International Journal of Molecular Sciences on best practices for the clinical use of genome-wide association study (GWAS) data. The article provides guidance for integrating imputed genetic information into healthcare in a way that supports accuracy, transparency, and clinical utility. Co-authored by...

GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine secures FDA clearance for new DWI sequence, significantly expanding the Swoop® system's clinical capabilities in acute neurological care....

DOVER, Del. & EPALINGES, Switzerland--(BUSINESS WIRE)--Pilatus Biosciences Announces FDA Clearance of IND Application for PLT012, a First-in-Class Anti-CD36 Metabolic Checkpoint Antibody in Solid Tumors...

ATLANTA--(BUSINESS WIRE)--Nephrodite, Inc., a medical device company developing an implantable, continuous renal replacement system, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s Holly™ implantable, continuous dialysis system. The designation recognizes Holly as a novel, transformative therapy addressing end-stage kidney disease (ESKD) which affects more than 850,000 people in the U.S., costing more than $50 billion...

VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that company management will present at the J.P. Morgan 2026 Healthcare Conference on January 12, 2026, in San Francisco, California. Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical, is scheduled to present on Monday, January 12, 2026, at 4:00 PM Pacific Time. The presentation will provide an upd...

BOCA RATON, Fla.--(BUSINESS WIRE)--Algia Pharma, LLC (“Algia”) today announced the company has received support from the U.S. Food and Drug Administration (FDA) to advance AlgiaPak® toward a Phase 2 clinical trial upon completion of Investigational New Drug (IND)-enabling studies. AlgiaPak is the company’s streamlined, multimodal pain formulation designed to treat all mild-to-moderate acute pain as effectively as opioids, without exposing patients to the risk of opioid addiction. The company ha...

CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved LEROCHOLTM (lerodalcibep-liga) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia...