AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (trastuzumab deruxtecan), in combination with pertuzumab, has received U.S. Food and Drug Administration approval as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer, based on results from the DESTINY-Breast09 Phase III trial. The approval marks the first new frontline treatment in over a decade […]
AstraZeneca has received European Commission approval for a new subcutaneous formulation of Saphnelo (anifrolumab), allowing adult patients with systemic lupus erythematosus (SLE) to self-administer the drug via a once-weekly pre-filled pen. The regulatory decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is supported by data from the Phase […]
LifeNet Health has announced the acquisition of Tissue Testing Technologies LLC (T3), a South Carolina–based biotechnology company specializing in advanced biopreservation. The deal expands LifeNet Health’s capabilities in organ and tissue preservation by integrating proprietary vitrification and warming technologies developed by Tissue Testing Technologies. The transaction is positioned to enhance clinical transplantation success rates, support […]
Milestone Pharmaceuticals’ CARDAMYST FDA approval marks a new era in PSVT care. Find out how this first‑in‑class nasal treatment could transform acute arrhythmia management.
Vaxxas Pty Ltd, the Australian biotechnology company known for its high-density microarray patch (HD-MAP) platform, has secured a manufacturing licence from the Therapeutic Goods Administration (TGA) to produce its investigational vaccine delivery system under Good Manufacturing Practice (GMP) conditions. The licence, granted for its Brisbane-based biomedical facility, clears a critical regulatory hurdle and allows Vaxxas […]
FDA fast-tracks review of Opdivo plus AVD for first-line Hodgkin lymphoma. Find out what this immunotherapy combo could change for patients and providers.
