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FDA Accepts sBLA Filing of Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Early Alzheimer's Treatment

immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the U.S., Japan, China, and South Korea with the following indications: About...

Agomab Receives FDA Orphan Drug Designation for AGMB-447 in Idiopathic Pulmonary Fibrosis

Disease and Idiopathic Pulmonary Fibrosis. We do this by targeting biologically validated pathways – including Transforming Growth Factor β and Hepatocyte Growth Factor - and by applying specialized capabilities in organ-restricted small molecules...

Tempo Therapeutics Appoints Eric I. Richman to Board of Directors

its synthetic tissue scaffold candidates based on the revolutionary Microporous Annealed Particle (MAP) technology platform into clinical trials, and the addition of Mr. Richman will maximize the chance for success and value." Eric has a...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

Thermo Fisher Scientific Introduces Innovative Mass Spectrometer to Advance Clinical Research

peptides, metabolites, and lipids. This workflow includes third-party software support via Thermo Scientific Ardia™ platform and high throughput liquid chromatography separation with the Thermo Scientific Vanquish™ Neo ultra-high performance liquid...

Bruker Launches Transformative neofleX MALDI-TOF System

Bruker Corporation announced the launch of a novel, high-performance MALDI-TOF/TOF system, the neofleX Imaging Profiler for mass spectrometry-based tissue imaging. It enables facile OME-TIFF file output via the new SCiLS Scope software. The...

Apotex Corp. Introduces Generic Fertility Treatment Injectable Cetrorelix® in the United States

needs with high-quality medication that is more accessible to everyone." Please refer to the complete Prescribing information here for information on Warnings and Precautions, Adverse Reactions and Contraindications. About Apotex Corp. Apotex Corp....

Orthofix Receives FDA 510(k) Clearance for Rodeo™ Telescopic Nail

to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative device indicated to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI). The nail implant serves to stabilize the...

Formosa Pharmaceuticals Strikes Licensing Deal with Tabuk Pharmaceuticals for Clobetasol Propionate Ophthalmic Suspension

Taiwan-based Formosa Pharmaceuticals announced today that the company has entered into an exclusive licensing agreement with Tabuk Pharmaceuticals Manufacturing Company ("Tabuk"), for exclusive rights to the commercialization of clobetasol...

FDA Clears Rika Plasma Donation System's Individualized Nomogram

as part of an extensive ecosystem including the MyataTM Customer Service Portal and the KinariTM Device Management Platform, which enables electronic software distribution. All this is anticipated to support center productivity and efficiency to...

ONFAB, High Potent Containment Provider, Expands into USA Market

ISO 9001 accredited. the internationally recognized standard for an organization's internal quality management. For more information please visit https://onfab.co.uk/.

FDA Approves Myhibbin™ by Azurity Pharmaceuticals, Inc., a Mycophenolate Mofetil Oral Suspension

Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced that the U.S. Food and Drug Administration (FDA) has approved...

Adcentrx Therapeutics: China NMPA Clears IND for ADRX-0706, a Novel Nectin-4 ADC in Advanced Solid Tumor Treatment

Adcentrx's innovative i-Conjugation™ technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded...

enGene to Showcase Pivotal Phase 1/2 LEGEND Study Details of EG-70 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

ongoing Phase 2 pivotal study. EG-70 was developed using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and...

Axion BioSystems Adds Affordable Maestro Volt™ to its Industry-Leading MEA System Lineup

over time is essential in neurological and cardiovascular research. Axion BioSystems’ next-generation Maestro MEA platform, which also includes the high-throughput Maestro Pro™ and the versatile Maestro Edge™, makes it easy for any scientist to...

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®

diseases. Wilate® is the first von Willebrand factor (VWF) concentrate indicated for prophylactic treatment across all forms of VWD, a significant patient treatment milestone for the most prevalent bleeding disorder in the United States. VWD...

Aurora enhances Australian offerings with premium dried flower range

as they continue to expand their offerings under the Aurora brand. The dried flower products are available now in four 10g formats including: "This expanded offering aims to serve patients with more choice, novel cultivars and expertly grown...

Cold Box Express, Inc. Introduces Refreshed Brand

Cold Box Express, Inc. (CBX) has announced a rebranding of both the company and its product the ClimateCrate™ (formerly COLD BOX). While the corporate company name remains Cold Box Express, Inc., the evolution to CBX simplifies the logo and helps...

TIVDAK® Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

the first antibody-drug conjugate with statistically significant prolonged overall survival data.” The U.S. Prescribing Information for TIVDAK includes a BOXED WARNING for Ocular Toxicity as well as the following Warnings and Precautions:...

Avenacy announces launch of Eptifibatide for Injection in the U.S.

facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. For more information, please visit http://www.avenacy.com/.