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 The FDA approved Voxelotor was withdrawn from the market five years after its 2019 launch due to safety concerns (e.g., higher rate of...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...
and restore the vision of patients with blinding retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec) for the...
to domestic production. More than 70 percent of the product units Fresenius ships in the U.S. are drugs listed on the FDA’s Essential Medicines List. About Fresenius Kabi: As a global health care company, Fresenius Kabi is Committed to Life. The...
products for clinical trials and commercial use. With our state-of-the-art aseptic plant and strict adherence to GMP and FDA standards, we deliver tailored solutions that guarantee safety, precision, and innovation in every product.
tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell...
Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November...
implementing lean operations and compliant quality systems that helped to pave the way for Food and Drug Administration (FDA) approval and the recent acquisition of Axonics by Boston Scientific. Prior to Axonics, Sama was the director of operations...
(sBLA) for less frequent intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. In October 2024, the rolling submission of a Biologics License Application (BLA)...
on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with metastatic de novo or treatment-emergent...
