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FDA approvals and label expansions in oncology and diagnostics
The FDA expanded the use of Jazz Pharmaceuticals’ bispecific antibody Ziihera (zimberelimab/see-through naming per original context) into a new frontline regimen for HER2-positive gastrointestinal...
Clinical trial readouts and safety-related holds
Regulators and sponsors continued to reshape development timelines in multiple programs. Regenxbio said the FDA placed a second clinical hold on its Hunter syndrome gene therapy after asymptomatic...
Big deals and licensing agreements reshaping drug portfolios
Roche and Genentech signed a major licensing agreement with Hanmi Pharmaceutical to develop and commercialize HM-17321, a long-acting urocortin-2 analog designed to reduce fat while preserving...
Cancer immunotherapy advances, including T-cell engagers and targeted immune modulation
Janssen reported a major milestone for teclistamab in refractory multiple myeloma through results from its MajesTEC-9 phase I/IIa trial. In a cohort of nearly 600 patients, teclistamab met its...
Genomic and spatial biology tooling for biomedical research
Researchers unveiled DREAMS, a tissue-aware method published in Nature Cell Biology designed to map DNA and RNA modification landscapes with spatial resolution. Unlike uniform-tissue averaging...
Alzheimer’s diagnostics and biomarker platform competition accelerates
Roche and Eli Lilly’s FDA clearance for the Elecsys pTau217 Plasma test adds momentum to blood-based Alzheimer’s workflows, offering a rule-in/rule-out framework for amyloid pathology using a...
Gene and cell therapy development faces repeated regulatory scrutiny
Gene therapy programs remained under intense regulatory review. Regenxbio’s Hunter syndrome asset faced a second FDA clinical hold after asymptomatic spine MRI masses were found in five enrolled...
Biomanufacturing innovation and process standardization
Biomanufacturing innovation focused on both productivity and analytical standardization. SynGenSys introduced CHO.SET 2.0 synthetic promoters to improve protein production in CHO cells, reporting...
Real-world evidence and diagnostics expansion in oncology screening
Guardant Health said it is gathering real-world validation data for its multi-cancer detection (MCD) assay, Shield MCD, which currently operates as an opt-in component to its FDA-approved...
Preclinical and translational immunology tied to innate sensors
cGAS–STING signaling continued to surface as a mechanistic node connecting genome instability, inflammation, and cancer immunity. A Nature Aging study found that cGAS-deficient mice show premature...
Alzheimer’s diagnostics expand with new Roche-Lilly FDA clearance and competitive landscape
The FDA cleared a new blood test for Alzheimer’s from Roche and Eli Lilly, aimed at ruling in and ruling out amyloid pathology using phosphorylated tau 217 (pTau217) levels. Roche’s Elecsys...
FDA approvals broaden Jazz’s Ziihera into frontline gastric cancer and expand market access
Jazz Pharmaceuticals won an FDA label expansion for Ziihera, moving the bispecific antibody into a frontline regimen for certain gastric cancer patients. The approval makes Ziihera a newly...
J&J’s Imaavy becomes first approved therapy for warm autoimmune hemolytic anemia in label expansion moves
Johnson & Johnson’s Imaavy received a US label expansion for warm autoimmune hemolytic anemia (wAIHA), positioning it as the first FDA-approved therapy specifically for the rare autoimmune...
Roche, Eli Lilly and broader blood-based biomarker momentum intensifies Alzheimer’s diagnostics competition
Alzheimer’s blood testing momentum accelerated again as FDA cleared additional biomarker assays and diagnostic players moved to integrate them into routine lab workflows. Analysts pointed to a...
Multiple myeloma: teclistamab T-cell engager delivers major progression and survival benefit in MajesTEC-9
Janssen Research & Development reported major results from the MajesTEC-9 Phase I/IIa trial of teclistamab in refractory multiple myeloma. In the study’s reported interim outcomes, teclistamab met...
Cardiovascular devices: correction to early-discharge safety data in ACURATE Neo TAVI study
A published correction fixed record-keeping issues in the POLESTAR trial evaluating early discharge safety and feasibility after ACURATE Neo transcatheter aortic valve implantation. The publisher...
Gene therapy setbacks: Regenxbio’s Hunter syndrome trial again paused under FDA clinical hold
Regenxbio said the FDA placed a second clinical hold on its Hunter syndrome gene therapy, RGX-121 (clemidsogene lanparvovec), after investigators found masses on spines of five patients in the...
Oncology devices: FDA grants humanitarian device exemption for Oncosil brachytherapy in distal cholangiocarcinoma
The FDA granted humanitarian device exemption (HDE) approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma. The approval makes Oncosil the first and only US...
Deals and collaborations: Roche and Genentech license Hanmi obesity therapy with muscle-preserving target
Roche’s Genentech unit signed a $2.3 billion licensing deal with Hanmi Pharmaceutical to develop HM-17321, a long-acting urocortin-2 (UCN2) analog designed to reduce fat while preserving muscle....
Digital health and compliance: FDA pilot and AI governance pressures for early trials and clinical site selection
The FDA is working with sponsors and stakeholders on a pilot program intended to accelerate first-in-human trials, with Amgen and Memorial Sloan Kettering cited among key participants. The effort...