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.
Avenzo shares Phase 1 data on CDK2 inhibitor AVZO-021 in HR+/HER2- breast cancer. Find out what it means for post-CDK4/6 resistance strategies in 2025.
Novo Nordisk’s semaglutide 7.2 mg achieves 20.7% weight loss. Find out what this EU regulatory step means for obesity treatment and patient outcomes in 2026.
Ivonescimab shows 80 percent response in TNBC Phase II study. Explore how Akeso’s bispecific strategy could reshape PD-1 therapy in first-line settings.
Swedish Orphan Biovitrum AB (Sobi) has entered into a definitive agreement to acquire Arthrosi Therapeutics Inc. for $950 million upfront and up to $550 million in milestone payments. The deal brings the investigational gout drug pozdeutinurad (AR882) into Sobi’s pipeline, positioning the oral URAT1 inhibitor as a potential anchor asset in a late-stage inflammatory franchise. […]
Zegenex, a Pittsburgh-based biotechnology company focused on regenerative wound care, has secured a $215,000 social-impact investment from the Richard King Mellon Foundation to accelerate formulation and preclinical development of Zegen-15, a first-in-class small-molecule cream targeting chronic wounds, including diabetic foot ulcers. The funding positions Zegenex to begin clinical trials by the end of 2026 and […]
Fondazione Telethon has received regulatory approval from the United States Food and Drug Administration for Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy designed to treat Wiskott-Aldrich syndrome, a rare X-linked primary immunodeficiency. This approval makes Waskyra the first gene therapy for this condition cleared for use in the United States and solidifies Fondazione Telethon’s […]
Spiderwort’s spinal cord scaffold earns scientific validation as its dermal filler enters human trials Spiderwort Biotechnologies Inc. has reported two key developments in its cellulose-based regenerative platform, signaling a step forward in both neurorepair and aesthetic medicine. A peer-reviewed study published in Scientific Reports confirms that the company’s plant-derived scaffolds promote neural tissue repair and […]
eClinical Solutions LLC has officially launched its elluminate AI agents, embedding agentic automation into its elluminate Clinical Data Cloud ecosystem. First previewed at the company’s ENGAGE conference in October 2025, these AI agents will become available in early 2026 and are designed to assist in four critical clinical trial workflows: data mapping, data review, risk-based […]
