Biotech & Medicine
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Scientists Build SpudCell, the First Synthetic Cell With a Complete Life Cycle
University of Minnesota researchers built SpudCell, a 90-kilobase synthetic cell that feeds, grows and divides, though outside scientists say it is not yet alive.
Frog Gut Bacterium Ewingella Americana Eliminates Colorectal Tumors in Mice With a Single Dose, JAIST Study Finds
A single intravenous dose of the frog-gut bacterium Ewingella americana produced complete tumor regression in every treated mouse in a colorectal cancer model, outperforming anti-PD-L1 immunotherapy and chemotherapy, JAIST researchers report in Gut Microbes.
FDA Approves Sanofi's Sarclisa Escena as First Anticancer Drug Delivered via Wearable On-Body Injector
The FDA cleared a subcutaneous, wearable-device formulation of Sanofi's multiple myeloma drug Sarclisa, the first cancer therapy approved for on-body injector delivery.
Cambridge Team Uses Precision Base Editing to Reveal NANOG's Essential Role in Human Embryo Development
Base editing knockout of NANOG in human embryos shows it is essential for the epiblast, the tissue that forms the body, arriving alongside a separate disease-gene editing study that has renewed debate over heritable genome editing.
Zanubrutinib-Rituximab Cuts Progression Risk 43 Percent in Frontline Mantle Cell Lymphoma in Phase 3 MANGROVE Trial
BeOne Medicines' chemo-free BRUKINSA plus rituximab regimen met its primary endpoint against bendamustine-rituximab in untreated mantle cell lymphoma.
Absentia Labs' AI 'Digital Liver' Becomes First AI Drug-Development Tool Accepted Into the FDA's ISTAND Program
Absentia Labs says its AI-driven Digital Liver Model is the first AI drug-development tool accepted into the FDA's ISTAND qualification pathway, at the Letter of Intent stage, to predict drug-induced liver injury.
Roche's Divarasib Beats Approved KRAS G12C Drugs Head-to-Head in Phase 3 Lung Cancer Trial
Roche says its next-generation inhibitor divarasib improved both progression-free and overall survival versus approved KRAS G12C drugs in a 338-patient Phase 3 NSCLC trial.
Taysha Completes Dosing in Pivotal Trial of Rett Syndrome Gene Therapy TSHA-102 as Longer-Term Data Show Sustained Developmental Gains
Taysha Gene Therapies has finished dosing 17 patients in the pivotal REVEAL trial of its Rett syndrome gene therapy TSHA-102 and reported longer-term Phase 1/2 data, setting up a planned BLA filing after a six-month interim analysis.
FDA Clears Casgevy for Children as Young as Two, Extending the First CRISPR Gene Therapy to Sickle Cell and Beta Thalassemia
The FDA approved expanded use of Vertex's CRISPR therapy Casgevy for patients as young as 2 with sickle cell disease or transfusion-dependent beta thalassemia, making roughly 5,500 more U.S. children eligible.
BridgeBio's Oral Infigratinib Adds 2.1 cm/Year of Growth in Achondroplasia Phase 3, Published in NEJM
PROPEL 3 met its primary endpoint, positioning infigratinib as a potential first oral rival to BioMarin's injectable Voxzogo. NDA filing is planned for Q3 2026.
FDA Approves Orca Bio's Tregzi, the First Regulatory T-Cell Therapy, to Cut Chronic GVHD After Stem-Cell Transplant in Blood Cancer
Tregzi lifted 12-month chronic-GVHD-free survival to 78% from 38% in the 187-patient Precision-T trial, becoming the first Treg-based immunotherapy the FDA has cleared.
FDA Clears EchoNext, the First Multicondition AI Tool to Flag Structural Heart Disease From a Standard ECG
The FDA cleared EchoNext, a deep-learning tool that reads a routine 12-lead ECG to flag six forms of hidden structural heart disease, outperforming cardiologists in a Nature study.