FDA News

CORALVILLE, Iowa--(BUSINESS WIRE)--Integrated DNA Technologies (IDT) is revolutionizing the field of translational gene editing with new additions to its end-to-end CRISPR portfolio....

SAN DIEGO--(BUSINESS WIRE)--Endeavor BioMedicines (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced that both the European Commission (EC) and the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to its investigational therapy, taladegib (ENV-101), for the treatment of idiopathic pulmonary fibrosis (IPF). Endeavor is cur...

CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF (ejection fraction) software, which uses AI to identify certain patients who may have a low left ventricular ejection fraction (LVEF). Tempus ECG-Low EF joins Tempus ECG-AF as the second FDA-cleared ECG-AI device in Tempus...

PALO ALTO, Calif.--(BUSINESS WIRE)--Genascence Corporation (“Genascence”), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001, a potential first-in-class gene therapy blocking interleukin 1 (IL-1) for the treatment of knee osteoarthritis (OA). GNSC-001 is a genetic medicin...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology. Guardant’s Shield™ MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—...

AUSTIN, Texas--(BUSINESS WIRE)--Wenzel Spine, Inc., a medical technology company focused on minimally invasive surgical and analytic solutions for spinal disorders, today announced it has received FDA clearance for its revolutionary expandable sacroiliac (SI) fusion implant, panaSIa. This milestone marks the first ever FDA clearance of an expandable SI fusion implant, offering a novel, minimally invasive solution for patients suffering from sacroiliac joint dysfunction. “We are excited to bring...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for SH-110, a palatable oral suspension to treat Glioma - a rare brain cancer - by providing a liquid form of treatment for patients who have difficulty swallowing. While SH-110 will increase coverage and compliance by allowing more flexibility in dose preparation and site of care, its...

NICE, France--(BUSINESS WIRE)--Caranx Medical (“Caranx”), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving procedure, today announced FDA clearance for US commercialization of the world's first AI Software for real-time intra-operative guidance of transcatheter heart valve implantation. The FDA clearance marks a significant milestone of Caranx's strategy towards planned ma...

CHICAGO--(BUSINESS WIRE)--Patients with liver diseases will have expanded access to advanced ultrasound imaging and transplant options, thanks to new policy allowing doctors to use contrast-enhanced ultrasound (CEUS) to help assess certain liver cancers and determine whether a liver is healthy enough for transplantation, according to experts affiliated with the International Contrast Ultrasound Society (ICUS). “This eliminates a significant roadblock to the appropriate use of CEUS at a time whe...