on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial...
their injection technique in the penis for the administration of XIAFLEX® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for Peyronie's disease. Do not receive XIAFLEX® if you have had an allergic reaction to...
with the potential to enhance both safety and efficacy as well as improve patient adherence and outcomes. “With the FDA’s recent commitment to phasing out traditional animal testing in favor of new approach methodologies, Creyon’s platform is...
Dx, The first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments. "Labcorp is dedicated to providing oncologists with a...
been CLIA-certified. The 1080 gene panel was validated against an orthogonal NGS panel, Illumina's TSO 500 and the FDA cleared PGDx panel at Dr. Ravindra Kohle's laboratory at Augusta University's Medical College of Georgia and was shown to have a...
preserve lean muscle mass during GLP-1 treatment for diabetes, weight loss, and chronic weight management. In keeping with FDA’s recent draft Guidance on using Artificial Intelligence, the TNF-Renova partnership is analyzing data from 30,000...
HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting HER2-low (IHC 1+ or IHC 2+/ISH-)...
in organ transplant technologies and services, today announced the successful completion of its hundredth case using the FDA-cleared KidneyVault™ Portable Renal Perfusion System. This milestone was achieved with the support of Tennessee Donor...
University. "The aim of the collaboration is to overcome mechanisms of drug resistance in cells exposed to Aramchol and FDA approved drugs. Based on these findings we would contemplate developing safe drug combinations that will block and...
Ede and Utrecht-based innovator spun out of neurovascular ELANA technology which was earlier brought to the market (CE and FDA) by the AMT team. With 27 employees and ISO 13485-certification, the company holds over 40 patents for its beating-heart...
company in Poland, brings a robust pipeline that includes multiple early-stage and late-stage biosimilars, along with two FDA/EMA-approved biosimilar products. With an extensive track record in delivering biosimilars for global markets, Chime...
for tissue regeneration and medical aesthetics, commented today, following the United States Food and Drug Administration (FDA)'s groundbreaking step announced last week to advance public health by replacing animal testing in the development of...
vitreoretinal clinics in Australia. Pykus intends to submit an Investigational Device Exemption (IDE) application to the FDA in Q4 2025 for a multicenter U.S. pivotal trial, pending financing and regulatory discussions. The Company plans to meet...
company pioneering innovative cancer therapeutics, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for "A Phase 1a/b Trial in Relapsed/Refractory Small Cell Lung...
over 40 countries, with approval from the European Medicines Agency (EMA) in 2019, the U.S. Food and Drug Administration (FDA) in 2021, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023.. With its exclusive pegylation...
a pioneering company in the field of regenerative medicine, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STM-01, the company’s neonatal cardiac progenitor cell (nCPC) therapy, for the treatment of...
boosting oral supplement in the United States†. Niagen Plus features pharmaceutical-grade Niagen (NR), compounded by U.S. FDA-registered 503B outsourcing facilities. It is available by prescription as intravenous (IV) and injectable Niagen. Niagen...
important therapeutic modality in this patient population with a high unmet need." Actinium has aligned with the FDA on a pivotal Phase 2/3 operationally seamless trial that will study Actimab-A + CLAG-M in r/r AML patients. The trial will optimize...
profile of CONTRAVE/MYSIMBA building on findings from prior clinical trials, a systemic literature review, two published FDA Adverse Event Reporting System (FAERS) database studies, and over ten years of post-marketing safety surveillance. These...
free of charge to eligible uninsured patients through its Patient Assistance Program (PAP). IMKELDI, which received FDA approval in November 2024, is now available for order through specialty distribution partners in the U.S. IMKELDI’s advanced...
