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Alzheimer’s blood-based diagnostics gain FDA validation
Roche and Eli Lilly won U.S. FDA clearance for the Elecsys pTau217 Plasma blood test, enabling clinicians to rule in and rule out Alzheimer’s disease in adults 55 and older presenting with...
Johnson & Johnson expands Imaavy to warm autoimmune hemolytic anemia
Johnson & Johnson’s Imaavy (isatuximab-irfc) secured a U.S. label expansion for warm autoimmune hemolytic anemia (wAIHA), making it the first FDA-approved therapy specifically for that rare...
FDA grants humanitarian device exemption for bile duct cancer
The FDA awarded a humanitarian device exemption (HDE) approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma. The decision makes Oncosil the first and only U.S....
Jazz and Actio strike $1.32B epilepsy acquisition
Jazz Pharmaceuticals agreed to acquire Actio Biosciences and its lead epilepsy drug ABS-1230 in a deal valued at about $1.32 billion. The acquisition expands Jazz’s epilepsy footprint amid...
Genentech and Hanmi expand obesity efforts with $190M upfront
Genentech, part of Roche, inked a metabolic pact with Hanmi Pharmaceutical to develop, manufacture, and commercialize HM-17321, a long-acting urocortin-2 (UCN2) analog. Genentech will pay Hanmi...
Chimeric Therapeutics shifts after cadherin-17 CAR T toxicity
Chimeric Therapeutics halted its phase I/II study of CHM-2101, a cadherin-17-targeted autologous CAR T for gastrointestinal cancers, after dose-limiting toxicities occurred in a second patient at...
Capricor’s deramiocel faces FDA schedule changes and review extensions
The FDA extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy deramiocel, deferring a decision after a negative advisory committee vote earlier in 2026. The agency...
Regenxbio gene therapy hit with another clinical hold for Hunter syndrome
Regenxbio said the FDA placed a clinical hold on its Hunter syndrome gene therapy RGX-121 after investigators found masses on spines of five patients enrolled in the Campsiite study. The company...
Guardant builds real-world dataset for Shield multi-cancer early detection
Guardant Health is collecting real-world validation data for its multi-cancer detection (MCD) test, which launched as an opt-in component to its Shield colorectal cancer screening offering. The...
Massachusetts biopharma rebound faces early funding headwinds
New reports from the Massachusetts Biotechnology Council show a rebound in seed deals and IPO activity alongside warning signs in federal funding and early-stage capital. MassBio’s industry...
Regulatory and label expansion
Janssen’s warm autoimmune hemolytic anemia therapy Imaavy (daratumumab?—not specified in the provided text) secured a Japan label expansion, marking the first approval specifically for warm...
FDA decision timeline and safety actions in gene therapy
FDA again paused Regenxbio’s Hunter syndrome gene therapy trial after investigators found masses on the spines of five treated patients, as reported by the company and covered by STAT+. Regenxbio...
Obesity partnerships and licensing deals
Genentech moved to deepen its obesity pipeline through a major licensing pact with Hanmi Pharmaceutical for HM17321, a long-acting urocortin-2 analog designed to reduce fat while preserving...
Late-stage cancer immunotherapy: mRNA neoantigen vaccine
Moderna and Merck reported positive Phase 3 outcomes for their individualized mRNA neoantigen vaccine, intismeran autogene, alongside Keytruda in resected melanoma. In the INTerpath-001 trial...
Clinical trial readout: T-cell engager in multiple myeloma
Janssen reported MajesTEC-9 Phase I/IIa results for teclistamab in refractory multiple myeloma, describing improvements across disease control endpoints in a trial population of nearly 600...
Cancer diagnostics and biomarkers: FDA clearance of blood test
Roche and Eli Lilly received FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, an assay intended to help identify amyloid pathology in Alzheimer’s disease. The test is designed...
Diagnostics supply chain integrity: antibody validation image manipulation
A scientific-integrity investigation expanded significantly on concerns about antibody validation image manipulation. Reese Richardson and collaborators reported finding more than 18,000...
Prequalification and global diagnostics access: WHO TB test pathway
WHO opened its prequalification pathway for targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics and interferon gamma release assays (IGRAs), establishing an...
AI and contract/device regulation oversight
FDA’s Center for Devices and Radiological Health (CDRH) continued its regulatory work for generative AI (GenAI)-enabled medical devices by asking stakeholders to engage with its discussion paper...
Funding for RNA/immune inflammation platform
OmicsBank raised $2.25 million to help bring overseas patient data to biopharma, aiming to expand data availability for model training and translational research use cases. The company’s focus...