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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...
FDA approval: ctDNA MRD-guided adjuvant immunotherapy
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab plus hyaluronidase-tqjs) as adjuvant treatment for muscle-invasive bladder cancer patients with...
Gene therapy progress toward submission: Duchenne micro-dystrophin milestone
Regenxbio said it cleared a key milestone in a pivotal study of its Duchenne muscular dystrophy gene therapy, generating the miniaturized muscle protein expression levels needed to support an FDA...
Precision oncology: RAGE blockade as a mechanistic link between aging and metastatic breast cancer
Researchers at Georgetown University’s Lombardi Comprehensive Cancer Center identified RAGE as a mechanistic driver of increased breast cancer metastasis with age, suggesting RAGE inhibition could...
FDA policy and staffing turbulence: CDER chief Tracy Beth Høeg expected to depart
Reuters reported that Tracy Beth Høeg, MD, PhD—acting director of the FDA’s Center for Drug Evaluation and Research (CDER) after the resignation of Richard Pazdur—was expected to leave the agency...
Rare disease drug under FDA clinical hold: Aardvark’s GLP-1 pathway program sidelined
The FDA placed a full clinical hold on Aardvark Therapeutics’ Prader-Willi syndrome drug program, stopping all tests of the company’s small-molecule candidate ARD-101 after a cardiovascular safety...
Create Medicines funding: in vivo CAR-T platform scales with $122M Series B
Create Medicines raised $122 million in a Series B round to advance its in vivo CAR-T platform across autoimmune disease and oncology programs, with early clinical dosing already underway. The...
High-impact financing: Isomorphic Labs lands $2.1B Series B for AI drug discovery scale-up
Isomorphic Labs secured a $2.1 billion Series B funding round led by Thrive Capital to scale its AI drug discovery engine and accelerate progress toward bringing programs to the clinic. The...
Genomics to therapeutics: DNA-guided CRISPR extends RNA targeting with Cas12
University of Florida researchers developed ΨDNA, a CRISPR system that uses a DNA guide scaffold to direct Cas12 nucleases to RNA targets, expanding the CRISPR toolkit beyond RNA-guided...
Neurodegeneration biology: single-cell mapping links peripheral immune infiltration to CNS inflammation in ALS
Northwestern University Feinberg researchers reported a multiomic analysis showing ALS progresses through a “domino-like” cascade that starts in motor neurons and is amplified by immune...
Biopharma innovation: Aardvark-unrelated molecular glue and oncology progress remain in pipeline
The 2026 AACR New Drugs on the Horizon session highlighted TRI-611, an FDA Fast Track-designated CNS-penetrant CRBN-mediated molecular glue degrader for ALK fusion-positive non-small cell lung...
FDA approves ctDNA MRD-guided Tecentriq in bladder cancer, with Natera CDx
The FDA on Friday approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as adjuvant treatment for muscle-invasive bladder cancer patients with...
Aardvark Therapeutics hit with full FDA clinical hold for Prader-Willi drug
Aardvark Therapeutics said the FDA has placed a full clinical hold on all tests of its Prader-Willi syndrome program, halting activity after a cardiovascular safety signal emerged earlier in...