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Regeneron to seek FDA OK after gene therapy restores hearing in children
Regeneron published trial results showing a gene therapy substantially improved hearing in children born with a specific genetic form of deafness and plans to file for regulatory approval....
Cambridge hematoids: lab‑grown embryo models generate human blood stem cells
Scientists at the University of Cambridge created three‑dimensional embryo‑like structures that recapitulate early human development and produce blood stem cells, according to new Cell Reports...
mRNA and molecular discoveries revive male fertility prospects
Researchers at the University of Osaka and Baylor College of Medicine reported an mRNA therapy that restored sperm production and fertility in mouse models carrying genetic defects. The...
Excellergy debuts with $70m to challenge Xolair — New allergy drug class
Excellergy launched with a $70 million Series A led by Samsara Biocapital to advance effector cell response inhibitors (ECRIs), a new therapeutic class designed to rapidly disarm IgE‑driven...
South Korea picks PacBio for national pangenome; Bio‑Techne expands nanopore tie‑up
The Korea Disease Control and Prevention Agency selected Pacific Biosciences' HiFi long‑read sequencing to build a telomere‑to‑telomere Korean pangenome reference, planning more than 1,000 whole...
Antibiotic pipeline and resistance tighten: Blacksmith gains QIDP as WHO warns
Blacksmith Medicines received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for FG‑2101, an LpxC inhibitor targeting Gram‑negative pathogens, securing potential...
Compute accelerates biology — GPUs and language models speed genomics
Unum and Nebius announced a GPU‑optimized release of StringZilla, accelerating sequence alignment and fingerprinting tasks critical to large‑scale omics and drug discovery workflows. The port...
Bristol Myers Squibb buys Orbital Therapeutics – $1.5bn bet on in vivo CAR T
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion in a deal that brings an in vivo cell-therapy platform into BMS’s immunology pipeline. Orbital’s technology delivers...
South Korea selects PacBio HiFi sequencing: national pangenome to map 1,000+ genomes
South Korea's Korea Disease Control and Prevention Agency and Korea National Institute of Health selected Pacific Biosciences’ HiFi long‑read sequencing as the primary platform for a national...
Bio‑Techne extends nanopore pact: portfolio push to commercialize heritable disorder tests
Bio‑Techne expanded its collaboration with Oxford Nanopore Technologies to develop and commercialize a broader portfolio of targeted enrichment kits for screening and diagnosing heritable genetic...
AI predicts pediatric sepsis: models flag high‑risk infants for earlier intervention
New machine‑learning models were shown to forecast pediatric sepsis risk, enabling clinicians to identify at‑risk infants earlier and prompt proactive care. The research demonstrates that AI...
Moderna previews mRNA antigen therapy: melanoma data disclosed ahead of ESMO
Moderna shared early clinical data for its mRNA cancer antigen therapy, mRNA‑4359, combined with Merck’s PD‑1 inhibitor prior to ESMO presentation. The company reported responses in patients with...
Regeneron to seek FDA approval: gene therapy restores hearing in children
Regeneron announced clinical results in The New England Journal of Medicine showing its gene therapy improved hearing in a cohort of children born with a rare genetic form of deafness. Nine of 12...
Radioligand therapy expands: China clears [177Lu] candidate as interest in RLT grows
Sichuan Biokin received China NMPA clearance to start clinical trials of [177Lu]‑BL‑ARC001, marking continued regulatory activity in radioligand therapy (RLT). Separately, a review of RLT in...
Base editing corrects LMNA mutations: cardiac disease prevented in mice
Researchers at the University of Texas Southwestern demonstrated targeted base‑editing strategies that corrected LMNA point mutations in patient‑derived iPSC cardiomyocytes and humanized mouse...
FDA on pace for fewest new‑drug approvals in years: 2025 shortfall tightens timelines
Industry reporting indicates the U.S. Food and Drug Administration is on track to approve the fewest new molecular entities since 2022, leaving more than a dozen companies waiting on regulatory...
Investors back novel oncology and AI drug discovery: Trogenix $95M, Meta‑Flux $2M
Two fundraising rounds illustrate selective investor activity: Edinburgh‑based Trogenix closed a $95 million Series A to advance its Odysseus AAV platform aimed at aggressive solid tumors, and...
FDA flags Novo Nordisk plant: OAI follows inspection tied to CRLs
The FDA has classified Novo Nordisk’s Bloomington, Indiana contract-manufacturing site as “official action indicated” (OAI) after inspection findings linked to complete response letters for drugs...
Regeneron to seek approval: gene therapy restores hearing in children
Regeneron said it will pursue regulatory approval after a clinical study—published in The New England Journal of Medicine—showed meaningful hearing gains in children treated for a congenital form...
Moderna previews melanoma antigen therapy: data behind program shift
Moderna released early clinical data showing responses in melanoma patients treated with its cancer antigen therapy (mRNA-4359) in combination with a PD-1 inhibitor, and separately posted Phase...