Samsung Bioepis Gains EC Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™) Samsung Bioepis Co., Ltd. has announced that the European Commission (EC) has granted marketing authorization for two denosumab biosimilars, OBODENCE™ (60 mg prefilled syringe) and XBRYK™ (120 mg vial), which…
MED-EL USA Gets FDA Approval for SONNET 3 Audio Processor MED-EL USA has announced the U.S. Food and Drug Administration (FDA) approval of its latest innovation, the SONNET 3 audio processor, designed for use with MED-EL cochlear implants. As the…
FDA Grants Full Approval to Deciphera’s ROMVIMZA™ (vimseltinib) for Symptomatic TGCT Ono Pharmaceutical Co., Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ROMVIMZA™ (vimseltinib), a kinase inhibitor, for the treatment of adult…
UroGen Shares ENVISION Trial Subgroup Analysis on Tumor Burden and UGN-102 Response UroGen Pharma Ltd. (Nasdaq: URGN) announced results from subgroup analyses of the pivotal ENVISION study, assessing the impact of tumor burden and focality on the response to UGN-102,…
IMFINZI® Regimen Boosts Survival in Muscle-Invasive Bladder Cancer: NIAGARA Phase III Post-Hoc Analysis A post-hoc exploratory analysis from the Phase III NIAGARA trial has shown that AstraZeneca’s IMFINZI® (durvalumab), when administered perioperatively with neoadjuvant chemotherapy, significantly improves event-free survival (EFS)…
Cancer Breakthroughs: Veracyte’s Decipher Tests and GRID Tool at ASCO GU Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced today that new data presented at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) highlight the clinical utility of…
CSL and Arcturus’ KOSTAIVE® Self-amplifying mRNA COVID-19 Vaccine Approved by European Commission CSL (ASX: CSL; USOTC: CSLLY), a global biotechnology leader, and Arcturus Therapeutics (Nasdaq: ARCT), a pioneer in self-amplifying mRNA (sa-mRNA) technology, have announced that the European Commission has…
Galderma’s Nemluvio® (Nemolizumab) EU Approval for Atopic Dermatitis and Prurigo Nodularis Galderma announced that the European Commission has granted approval for Nemluvio® (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio, a…
DaVita Inc. Q4 2024 Results DaVita Inc. (NYSE: DVA), a leading provider of dialysis services, has announced its financial and operational results for the fourth quarter and year ended December 31, 2024. Despite facing challenges throughout the year, DaVita achieved…
OrthoNebraska Chooses Health Catalyst Ignite™ for Data-Driven Care Health Catalyst, Inc. (Nasdaq: HCAT), a leader in data and analytics technology for healthcare organizations, has announced a multi-year partnership with OrthoNebraska, a prominent orthopedic care provider based in Omaha, Nebraska. This…
Sigma Healthcare Merges with Chemist Warehouse Sigma Healthcare has officially merged with Chemist Warehouse Group (CW), marking a monumental moment for both companies. As of today, the newly merged entity’s shares are trading on the ASX, signaling the start of…
Waystar Named Leading AI-Powered Software Platform Waystar Holding Corp. (Nasdaq: WAY), a leader in healthcare payment software, has been recognized as the industry’s top AI-powered software platform by Black Book Market Research™. In an independent survey assessing AI-driven revenue cycle…