Mirum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC).
Pulse Biosciences, Inc. a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel CellFX nsPFA Percutaneous Electrode System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
Mikart, LLC, a leading Contract Development and Manufacturing Organization (CDMO), announces the addition of cutting-edge, Fette® double-sided tablet presses to bolster its production capacity and meet the product demands of its increasing number of clients.
HemoSonics, LLC, a medical device company focused on acute bleeding management, announced that its Quantra Hemostasis System with QPlus® and QStat® Cartridges has been named a finalist in the 2024 Edison™ Awards.
Fresenius Kabi announced it has introduced Posaconazole Injection, a generic substitute for Noxafil®, for use in treating or preventing serious fungal infections in adults and children who have an increased chance of getting these infections due to a weakened immune system. Now available in the U.S., Posaconazole Injection is the newest addition to Fresenius Kabi’s portfolio of more than 30 anti-infective molecules.
Bruker Corporation announced a definitive agreement for the acquisition of Chemspeed Technologies AG, a Swiss provider of vendor-agnostic automated laboratory R&D and QC workflow solutions. Chemspeed is focused on modular automation and robotics solutions for chemical research, pharma drug formulation, materials research for cleantech and consumer applications.
Orthofix Medical Inc.a leading global spine and orthopedics company, announced it has entered into an agreement with MRIguidance to distribute its BoneMRI™ imaging software in the U.S.
Credence MedSystems, an innovator of drug delivery systems that solve unmet market needs for the pharmaceutical industry, announced that it has successfully completed Factory Acceptance Testing (FAT) for production of its Companion® injection device platform on the Company's new Clinical Assembly Line.
Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) .
HR Pharmaceuticals, Inc. (HRP) announced that they have entered into an Exclusive Commercial Agreement with Poiesis Medical LLC, under which HRP will license Poiesis's Dual Balloon Catheter (Duette™).