ocular therapeutics. Novaliq developed EyeSol®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol® medicinal products for dry eye disease – Miebo® and Vevye® – are on the market in the United States revolutionizing...
(denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States. These denosumab biosimilars are approved by the FDA for all indications of the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively. Conexxence is...
a dispersed network of independent distributors across the United States. About VersaWrap® Hydrogel Sheet: VersaWrap is an FDA-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous...
Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also known as...
patients,” said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals. “Pending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to...
from sample to result. "Traceability plays an important role in the security and integrity of pharmaceutical data, and the FDA considers the absence of records to be highly significant when data discrepancies are observed," said James Hallam, Vice...
estimated 130,180 deaths annually in the United States alone.1 In the last 10 to 15 years, accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma have been possible in part due to advances in molecular...
models continue to support the pharmaceutical and biotechnology industry’s shift away from animal models as recognized by FDA Modernization Act 2.0 which allows drug developers to submit non-animal data to demonstrate safety and efficacy of...
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...
