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 The FDA approved Voxelotor was withdrawn from the market five years after its 2019 launch due to safety concerns (e.g., higher rate of...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...
the trial, as we work toward bringing a new therapeutic option to oncology patients." Trial Design and Advancements: The FDA approved the Phase 1a accelerated dose-escalation design based on extensive research, prior clinical testing, and the...
brain disease, announced on the "Neurophet AQUA", has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis functionality. The initial clearance, secured in May last year,...
Hanmi obtained approval from both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) to modify the Phase 1 trial plan to evaluate BH3120 in combination with KEYTRUDA. Full-scale clinical development is...
the clinical potential of this study "Similar to the first gene editing technology-based treatment that received FDA approval last year, I would like to see approval for a treatment based on mitochondrial gene editing technology for mitochondrial...
become a widely available, standardized treatment for a dangerous and potentially fatal condition. As we await potential FDA review and approval, and prepare to launch the LipidRescue Kit, I'm very thankful to the many physicians, researchers,...
Imaging S.p.A., a leading global company in the diagnostic imaging business, is proud to announce that its most recently FDA-approved magnetic resonance imaging (MRI) agent, VUEWAY® (gadopiclenol) solution for injection, has reached over one...
