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FDA greenlights ctDNA MRD-guided adjuvant immunotherapy in bladder cancer
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza (subcutaneous atezolizumab and hyaluronidase-tqjs) as adjuvant treatment for patients with muscle-invasive bladder...
Phase 3 readout for telitacicept in IgA nephropathy
RemeGen’s telitacicept delivered a strong interim efficacy signal in a prespecified Phase 3 analysis in high-risk IgA nephropathy, according to results presented at NEJM.org and associated meeting...
New gene therapy targeting liver for hemophilia A
Researchers reported efficacy improvements with two engineered AAV8 vectors—HMR-001 and its codon-optimized counterpart HMR-001z—in a hemophilia A gene therapy study focused on restoring...
Aardvark hits full FDA clinical hold after cardiovascular signal
FDA placed Aardvark Therapeutics’ Prader-Willi syndrome program under a full clinical hold, halting further testing of ARD-101 and related studies following a cardiovascular safety issue observed...
Gene therapy safety case raises AAV integration scrutiny
A CHOP-led team presented evidence of a brain tumor linked to rare adeno-associated virus (AAV) integration, highlighting a potential long-term risk to the AAV gene therapy field. The case,...
Telitacicept, Tecentriq, and beyond—drug pipeline momentum in gene and RNA therapy
ASGCT’s Q1 2026 Landscape Report pointed to accelerating regulatory and funding activity across gene and RNA therapies, with an increase in startup funding and a reported uptick in approval...
In-vivo CAR platform advances with $122M Series B funding
CREATE Medicines secured a $122 million Series B round to advance its in vivo CAR platform, with lead assets spanning autoimmune disease and oncology. The company’s proprietary mRNA-LNP platform...
Contract research and diagnostics: ARUP launches infectious disease testing dashboard
ARUP launched a public-facing infectious disease testing dashboard intended to provide near real-time signals on positivity rates across selected molecular assays. The reference lab said the...
Precision oncology: MYC linked to urothelial cancer mortality and microenvironment
Researchers tied urothelial carcinoma disease biology and outcomes to MYC overexpression, implicating a tumor-intrinsic mechanism for disease progression and treatment resistance. The work...
New in-orbit pharma manufacturing partnership
Varda Space Industries announced a partnership with United Therapeutics to test small-molecule drug development using Varda’s in-orbit experiment platform. Varda has been sending automated...
FDA precision oncology approval with ctDNA MRD testing
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer patients who are ctDNA-positive after cystectomy, as determined...
Phase 3 trial results for telitacicept in IgA nephropathy
Telitacicept, a BAFF/APRIL-targeting fusion protein by RemeGen, delivered a significant reduction in proteinuria in an interim analysis of a Phase 3 trial in high-risk IgA nephropathy. The...
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...