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...
Latigo Biotherapeutics ("Latigo") announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to LTG-001, the company's oral, investigational selective Nav1.8 inhibitor for the treatment of acute pain. LTG-001...
that still may not cure pain. Further, due to the complexity of SCD pathobiology many drugs are themselves toxic. The FDA approved Voxelotor was withdrawn from the market five years after its 2019 launch due to safety concerns (e.g., higher rate of...
hands (2% to 5%). To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Concomitant use of calcitonin-salmon and lithium may lead to a reduction in...
of O2 Fitness, now offers KYZATREX® (testosterone undecanoate) CIII capsules to its patients nationwide. KYZATREX is an FDA-approved oral testosterone therapy designed to treat adult men with low or no testosterone due to certain medical...
both cervical and lumbar implants with anatomically-differentiated designs. Centinel Spine is the only company with FDA approval for both cervical and lumbar TDR systems. All prodisc cervical and lumbar devices incorporate prodisc CORE technology,...
treatments that combine digital therapeutics with comprehensive care. Stanza, its flagship product, is the first FDA-cleared digital therapeutic indicated for treating fibromyalgia symptoms, designed to provide patients with tools to better manage...
