on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive...
pipelines for target discovery, lead optimization, and safety prediction. A Timely Answer to Shifting Regulations With the FDA targeting animal studies to become “the exception rather than the norm,” the need for proven human models is urgent....
Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. Doxycycline for Injection, USP had U.S. sales of approximately $47 million for the...
and distribution facilities. More than 70% of the units shipped by Fresenius Kabi in the U.S. are drugs listed on the FDA’s Essential Medicines List. To learn more, visit our More in America page. IMPORTANT SAFETY INFORMATION: Do not inject into...
Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....
recognized for its groundbreaking clinical-grade exosome products and leadership in regenerative science. Using an FDA-approved, pre-COVID single-donor perinatal MSC cell line, Kimera produces purified, cell-free exosome biologics in its 27,000 sq....
function," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "Following productive FDA interactions and positive topline results from the Phase 1b trial, we have designed our RENEW trial to test the promise of...
facilities, including Wells Pharma of Houston, which adhere to stringent testing standards as required by the U.S. FDA, which ensures compliance with US Pharmacopoeia (USP) particulate matter and bacterial endotoxin guidelines. About Niagen...
AI-driven platform enhances outcomes while reducing side effects. This pioneering and disruptive development has led to a FDA Breakthrough Device Designation for INBRAIN’s BCI-Tx in Parkinson’s Disease. In collaboration with partners like Merck...
refractory to treatment options highly responsive to LANCL2 drugs. Dr. Bassaganya-Riera added, “Despite a multitude of FDA-approved treatments and the emergence of combination treatments for UC and CD, there remains a significant unmet clinical...
innovative Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD) has received U.S. Food and Drug Administration (FDA) approval of its Premarket Approval (PMA) application. This positive decision paves the way for the Jewel Patch-WCD to offer...
next infectious disease. Longhorn’s core diagnostic product, PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA cleared, state-of-the-art ambient temperature molecular diagnostic collection and transport device that can help...
with its innovative lipid nanoparticle (LNP) delivery technology, today announced the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to its investigational mRNA...
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...
