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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...
Regenxbio’s Duchenne gene therapy clears pivotal bar, aims for FDA submission
Regenxbio reported that its Duchenne muscular dystrophy gene therapy met the primary bar in a pivotal study, generating a roadmap toward an FDA submission. The result centers on sufficiently high...
Create Medicines closes $122M Series B to scale in vivo CAR-T pipeline
Create Medicines raised $122 million in a Series B financing to advance its in vivo CAR-T platform across autoimmune disease and oncology. The company, formerly known as Myeloid Therapeutics, uses...
Isomorphic Labs secures massive $2.1B Series B to scale AI drug discovery
Isomorphic Labs, the Google-backed AI drug discovery company, secured a $2.1 billion Series B round as it looks to scale its AI drug design engine and move therapeutic programs closer to clinical...
Boehringer Ingelheim pays up to $478M for Immunitas antibody program in inflammation
Boehringer Ingelheim agreed to acquire global rights to a preclinical antibody program from Immunitas Therapeutics, adding a chronic inflammatory and autoimmune asset to its immunology pipeline....
Sonomind raises €20M Series A for ultrasound neuromodulation in depression
Sonomind SAS raised €20 million (US$23 million) in a Series A round to advance its ultrasound-based neuromodulation device for treatment-resistant depression. The company will use the funds to run...
EU seals Critical Medicines Act pact to shore up drug shortages
The EU reached agreement on the Critical Medicines Act, aiming to reduce shortages by boosting European manufacturing capacity for drugs and active ingredients and enabling coordinated procurement...
ARUP launches public infectious disease testing dashboard to tighten signal detection
ARUP launched a public-facing dashboard tracking weekly positive results for selected infectious disease tests, aiming to close gaps in digital epidemiology. The system provides de-identified,...
AAV gene therapy linked to brain tumor after rare integration event reported in NEJM
A team at Children’s Hospital of Philadelphia (CHOP) reported a rare case of a neuroepithelial tumor associated with adeno-associated virus (AAV) integration following intracisternal magna vector...