Get the Daily Brief
Latest Biotech News
FDA ctDNA MRD approval expands precision oncology
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer (MIBC) patients who are ctDNA-positive after cystectomy based on...
FDA clinical hold stalls rare disease metabolic drug program
Aardvark Therapeutics’ Prader-Willi syndrome program hit a roadblock as the FDA placed a full clinical hold on ARD-101. The hold escalates an earlier trial pause after a cardiovascular safety...
Gene therapy field tracks renewed momentum as sector reports cite approvals and startup funding
The ASGCT’s Q1 2026 Landscape Report highlighted a growing gene-, cell-, and RNA-therapy pipeline alongside increased startup funding. ASGCT CEO David Barrett said 42 gene therapies and 38 RNA...
CAR-T manufacturing and access models expand beyond traditional pathways
A European access model is gaining attention for how CAR-T therapies could reach more patients outside major centers. The University of Barcelona described a not-for-profit, hospital-exemption...
Create Medicines raises $122M to scale in vivo CAR-T immune programming
Create Medicines secured a $122 million Series B to advance its in vivo CAR-T pipeline across oncology and autoimmune disease. The Cambridge-based company’s platform uses mRNA-lipid nanoparticle...
Immunology deal: Boehringer licenses preclinical antibody for autoimmune and inflammatory disease
Boehringer Ingelheim struck a licensing deal with Immunitas Therapeutics for a preclinical antibody program aimed at chronic inflammatory and autoimmune diseases. Financial terms call for an...
CRISPR expands beyond RNA guides with DNA-guided Cas12 for RNA targeting
Researchers at the University of Florida unveiled a DNA-guided CRISPR-Cas12 approach designed to target cellular RNA using a DNA-based guide scaffold instead of guide RNA. The work, published in...
Checkpoint inhibitor MRD-guided bladder regimen sets a precedent for blood-based companion diagnostics
The same regulatory decision that backed Tecentriq MRD selection also highlighted the FDA’s first authorization of a blood-based MRD assay as a companion diagnostic. Signatera was authorized to...
Oncology diagnostics: FDA clears Datar Cancer Genetics comprehensive solid tumor profiling test
The FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling of solid tumors. The dual-analyte test uses targeted next-generation sequencing to assess DNA...
AI-enabled clinical operations: CRO launches automated biostatistics platform to speed trial readouts
Veristat rolled out InStat, a fully automated biostatistics platform built to compress clinical trial readout timelines from weeks to days. The system is designed to generate submission-ready...
FDA leadership shuffles after Makary exit
FDA leadership began another round of upheaval after commissioner Marty Makary resigned, according to multiple reports. The shakeup is already rippling through the agency’s drug review leadership...
Gene therapy and advanced modalities: Duchenne gene therapy heads toward FDA filing
Regenxbio reported that its Duchenne muscular dystrophy gene therapy met a pivotal clinical milestone, aiming the program toward an FDA submission. The company said the therapy achieved...
Precision oncology approval: ctDNA MRD-guided Tecentriq in bladder cancer
The FDA approved the first ctDNA MRD-guided adjuvant therapy in bladder cancer, authorizing Genentech’s Tecentriq and Tecentriq Hybreza for muscle-invasive disease with detectable circulating...
Immune oncology trial readouts: pembrolizumab plus lenvatinib in mucosal melanoma
A peri-operative Phase II study reported encouraging results for pembrolizumab combined with lenvatinib in mucosal melanoma, according to findings published in Nature Communications. The regimen...
RNA therapeutics/commercial transition: Ionis enters a new product era
Ionis is positioned to move from partnering toward commercializing products as it expands beyond rare indications, according to an industry product-focused review. The company’s near-term agenda...
FDA clinical hold: Aardvark’s Prader-Willi program in limbo
The FDA placed a full clinical hold on Aardvark Therapeutics’ Prader-Willi syndrome program, halting all tests of its small-molecule candidate ARD-101. The hold escalated a trial stoppage that...
In vivo CAR-T financing: CREATE Medicines raises $122M
CREATE Medicines closed a $122 million Series B round to advance in vivo CAR-T programs across autoimmune disease and oncology. The financing is aimed at progressing candidates built on the...
Ultrasound neuromodulation startup funding: Sonomind raises €20M
Sonomind SAS raised €20 million in a Series A round for its ultrasound-based neuromodulation platform targeting depression. The company plans to use the funding for clinical trials of its...
Next-gen AI for trials: Veristat launches InStat biostatistics automation
Veristat launched InStat, a fully automated biostatistics platform intended to shorten clinical trial data readouts from weeks to days. The CRO positioned the tool to generate submission-ready...
China-to-global dealmaking and major venture scale in AI drug discovery
Isomorphic Labs secured a large-scale Series B financing to push its AI drug design engine and expand toward clinical development. The company said a syndicate led by Thrive Capital provided $2.1...