Immunome’s Phase 3 varegacestat data could redefine gamma secretase inhibition in desmoid tumors
Immunome is set to release pivotal Phase 3 varegacestat data in desmoid tumors. Find out what the RINGSIDE results could change for the field.
Milestone Pharmaceuticals’ CARDAMYST nasal spray wins FDA approval: A new chapter for self-administered PSVT treatment
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 earns GMP licence for HD-MAP production—what this unlocks for clinical trials
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 […]
Is Avenzo’s AVZO-021 the next big player in HR+/HER2- metastatic breast cancer?
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.
Sobi bets $950m on Arthrosi to reshape chronic gout treatment with pozdeutinurad
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. […]
What the TRACERx study reveals about Personalis’ MRD technology in NSCLC
Personalis, Inc. has reported pivotal findings from its NeXT Personal assay in a new Cell publication, highlighting the test’s ability to detect molecular residual disease in stage I to III non-small cell lung cancer. The study, part of the TRACERx initiative and led by Professor Charles Swanton of the Francis Crick Institute and University College […]
How AidaBreast’s multi-omic insights may reduce overtreatment in breast cancer care
Prelude Corporation has announced the first independent validation of AidaBreast, a multi-omic diagnostic test developed to predict both locoregional recurrence risk and individualized radiation therapy benefit in early-stage hormone receptor-positive, HER2-negative invasive breast cancer. The study, conducted at Royal Melbourne Hospital and presented at the San Antonio Breast Cancer Symposium 2025, evaluated over 400 women […]
Spiderwort Biotechnologies’ cellulose scaffolds show promise in spinal cord repair
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 […]
What sterile drug manufacturers should expect from AST and Marchesini in 2026
AST, a United States-based provider of aseptic fill-finish systems for pharmaceutical and biotech manufacturers, has entered a strategic partnership with Italy’s Marchesini Group, a global leader in pharmaceutical packaging machinery. Under the agreement announced on December 10, 2025, Marchesini Group has acquired a 44.39 percent equity stake in AST. The deal aims to combine AST’s […]
How Innoviva’s NUZOLVENCE could reshape STI care and resistance strategy
Innoviva Specialty Therapeutics has received approval from the U.S. Food and Drug Administration for NUZOLVENCE (zoliflodacin), a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents. This approval, based on the largest-ever Phase 3 clinical trial for a new treatment against Neisseria gonorrhoeae, marks the first new oral gonorrhea […]