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New FDA approval in oncology: Beqalzi enters the US for mantle cell lymphoma
Beone Medicines’ next-generation BCL2 inhibitor sonrotoclax received accelerated approval from the US FDA for relapsed or refractory mantle cell lymphoma (MCL) after treatment with a BTK...
Gene therapy and cellular therapy milestones: first-in-US in vivo CAR-T dose
Physicians at Emory University’s Winship Cancer Institute administered what they describe as the first investigational in vivo CAR-T cell therapy dose in the United States for relapsed or...
Obesity drug strategy and maintenance: oral options and dosing shifts gain traction
Multiple new findings reinforce that weight-loss maintenance is becoming a key competitive battleground for GLP-1-based therapies. In a trial presented at ECO 2026, switching from injectable...
Liquid biopsy diagnostics: Medicare expands coverage for Personalis’ NeXT Personal
Personalis’ NeXT Personal minimal residual disease (MRD) assay gained expanded Medicare coverage under MolDX, extending reimbursement to immunotherapy monitoring across late-stage solid tumors....
Liquid biopsy workflow automation: Avant Genomics raises for standardized sample prep
Avant Genomics raised more than $3 million to develop and scale its cartridge-based liquid biopsy sample preparation platform, Avant Source. The company says it automates cell-free DNA extraction...
Proteomics and platform IP: Seer sues Nanomics over protein enrichment patents
Seer filed a patent infringement lawsuit against Nanomics Biotechnology, targeting multiple Seer intellectual property claims tied to nanoparticle-based protein enrichment technologies. The...
Proteins in motion and AI-driven structure prediction reach the clinic-adjacent frontier
New AI-driven research demonstrated models that generate protein structures in motion with atomic-level detail, aiming to capture both static folding and dynamic behavior important for drug and...
Antibiotic discovery with AI: ApexGO boosts peptide antibiotic optimization
Researchers at the University of Pennsylvania introduced ApexGO, an AI method designed to improve peptide antibiotic candidates rather than relying on broad screening of very large molecular...
BMS and Hengrui expand oncology pipeline via large early-development pact
Bristol Myers Squibb (BMS) and Hengrui Pharma announced a collaboration spanning 13 early-stage programs across oncology, hematology and immunology, with an aggregate value potentially exceeding...
First-in-US in vivo CAR-T dose enters multiple myeloma trial
Physicians at the Winship Cancer Institute of Emory University administered the first investigational in vivo CAR-T therapy dose in the United States for patients with relapsed or refractory...
FDA approval adds first US BCL2 inhibitor option for mantle cell lymphoma
Beone Medicines’ next-generation BCL2 inhibitor sonrotoclax (Beqalzi) won U.S. FDA accelerated approval for patients with relapsed or refractory mantle cell lymphoma after treatment with a BTK...
Roche pushes into end-to-end oncology diagnostics via PathAI and Saga moves
Roche outlined its plan to become an end-to-end oncology solutions provider, combining new acquisitions in diagnostics with sequencing and monitoring ambitions. Roche said it expects strong...
US FDA leadership shake-up raises regulatory uncertainty for biotech
Marty Makary resigned as FDA commissioner, and Kyle Diamantas, the agency’s top food official, stepped in as acting commissioner. Biotech industry watchers said the sudden leadership change leaves...
AI-driven antibiotic optimization delivers lab and in vivo activity
Researchers at the University of Pennsylvania reported ApexGO, an AI-powered method designed to improve peptide antibiotic candidates starting from a small set of imperfect molecules and iterating...
New gene therapy data in Dravet syndrome adds dose-dependent seizure control and developmental signals
Encoded Therapeutics presented additional Phase I/II POLARIS data for ETX101, an AAV9-based gene regulation therapy intended to increase SCN1A expression in children with Dravet...
Iterative Health raises $77M to expand AI-enabled trial enrollment network
Iterative Health secured $77 million in a Series C round to expand its AI-enabled clinical trial enrollment services and scale operations across cardiology and obesity trials. The company said...
Pacific Edge seeks funding as Medicare coverage path for bladder risk assays continues
Pacific Edge raised NZ$25.4 million (about $15.1 million) via a share placement to support operations and pursue Medicare coverage for its Cxbladder Triage assay. The company said it expects...
Rare gene-editing therapy for urea cycle disorder meets heightened scrutiny
At ASGCT 2026, Kiran Musunuru cautioned that a high-profile gene-editing case for urea cycle disorder should not be treated as a cure and was not a substitute for controlled clinical evidence. In...
FDA leadership shake-up
Marty Makary resigned as FDA commissioner, with Kyle Diamantas stepping in as acting commissioner, according to multiple reports. The transition ends a tenure that accelerated some biotech-focused...
Oncology diagnostics scale-up at Roche
Roche outlined a push to become an end-to-end oncology solutions provider, anchored by acquisitions in cancer diagnostics and expansion of its sequencing and pathology ecosystem. During its...