Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced it has introduced Dalbavancin for Injection (for single-dose regimen use only), which is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram-positive microorganisms.
Odyssey Therapeutics, Inc., a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that precisely target disease pathology, announced the appointment of Dennis Dean, Ph.D., as Executive Vice President and Head of Non-Clinical Development.
Eisai Co., Ltd. and Biogen Inc. announced that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.
Veloxity Labs, a bioanalytical CRO built for programs that need speed with purpose, announced the acquisition of the ZenoTOF 8600 system from SCIEX, a global leader in life science analytical technologies. Veloxity is the first bioanalytical CRO in the United States to acquire this new accurate mass spectrometer, with delivery expected later this year and installation/qualification starting January of 2026.
Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the launch of a new syringe for its category-leading hyaluronic acid (HA) brand BELOTERO®. The new syringe is ergonomically engineered to elevate the treatment experience, offering greater precision, comfort, and ease of use. The new syringe will launch first in Europe and then will expand to markets worldwide.
Servier announced longer-term data from the Phase 3 INDIGO trial evaluating VORANIGO® (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (mIDH1/2) glioma following surgical intervention and for whom chemoradiotherapy can be delayed were published in The Lancet Oncology.
InterVene, Inc., a privately held medical device company pioneering interventional devices for venous occlusions, announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Recana® Thrombectomy Catheter System for treating venous in-stent restenosis and native vessel obstructions.
Regeneron Pharmaceuticals, Inc. announced five-year follow-up results on overall survival (OS) from the Phase 3 EMPOWER-Lung 3 trial, which evaluated Libtayo® (cemiplimab) plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations.
Medtronic plc a global leader in healthcare technology, announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed™ 780G system for use in adults 18+ with insulin-requiring type 2 diabetes.
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with evolving international standards that increasingly recommend two doses to provide stronger, longer-lasting protection against varicella.