Esperion announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients.
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that the company has shipped approximately 440,000 doses of SKYCellflu® to Biogenetech in Thailand from its vaccine manufacturing facility 'L HOUSE' in Andong, South Korea.
Entourage Phytolab, under the leadership of Brazilian entrepreneur Caio Abreu, announces its launch on One Lavi. Known for its commitment to quality and innovation, Entourage Phytolab is set to bring its Entourage Liquid Fusionner™ – Night Use product to the leading online platform for health, beauty, and wellness products.
Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, announced it has launched Furosemide for Injection in the United States as a therapeutic equivalent generic for Lasix® for Injection (furosemide) approved by the U.S. Food and Drug Administration.
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.