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FDA clinical hold disrupts Aardvark’s Prader-Willi program
The FDA placed a full clinical hold on Aardvark Therapeutics’ ARD-101 and related studies for Prader-Willi syndrome after a cardiovascular safety signal emerged in a higher-dose healthy volunteer...
Gene editing platform shift: DNA-guided CRISPR targets cellular RNA
Researchers at the University of Florida reported a DNA-guided CRISPR–Cas12 system (ΨDNA) that directs Cas12 nucleases to RNA targets using DNA guide scaffolds rather than RNA guides. The...
Telescoping microbial medicine: implantable living materials contain bacteria yet deliver on demand
Harvard’s Wyss Institute and engineering collaborators described implantable living materials (ILMs) that confine engineered bacteria inside a hydrogel while enabling autonomous therapeutic...
Biopharma funding: CREATE Medicines raises $122M for in vivo CAR programs
CREATE Medicines secured a $122 million Series B round to expand its in vivo immune programming platform across autoimmune disease and oncology. The company’s mRNA-LNP approach is designed to...
Startup investing: Isomorphic lands $2.1B to scale AI drug discovery models
Isomorphic Labs announced a $2.1 billion Series B funding round led by Thrive Capital, one of the largest biotech venture raises in recent years. The company’s stated goal is to scale its...
Diagnostic regulatory milestone: FDA clears Datar Cancer Genetics solid tumor genomic profiling test
Datar Cancer Genetics received FDA clearance for its CellDx-Tissue comprehensive genomic profiling assay to profile DNA and RNA from solid tumors. The targeted next-generation sequencing panel...
Regulatory climate: EU reaches Critical Medicines Act pact to curb shortages
The EU reached an agreement on the Critical Medicines Act, aimed at reducing shortages by boosting manufacturing capacity and strengthening joint procurement for critical drugs, including orphan...
Immunotherapy pipeline preclinical/biology milestone: neuron and immune interplay in ALS
Northwestern University researchers reported a Nature Neuroscience study that maps a peripheral-to-central immune cascade in ALS. The work links early TDP-43 pathology inside motor neurons to...
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...