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FDA shifts peptide access via advisory vote on compounded products
An FDA advisory committee narrowly endorsed expanding access to several compounded, unapproved peptides, delivering a procedural win for proponents of the substances and for Health Secretary...
Lilly advances obesity ‘triple-G’ retatrutide toward US filing after additional Phase 3 readouts
Eli Lilly moved closer to an FDA submission for retatrutide after reporting additional late-stage obesity Phase 3 results across tougher co-morbid populations, including type 2 diabetes and...
GSK cashes in acquisition as FDA approves first NSCLC drug from Nuvalent deal
GSK received an FDA approval for zidesamtinib, branded Jideytro, in ROS1-positive metastatic non-small-cell lung cancer shortly after closing its $10.6 billion Nuvalent acquisition. The...
EU regulator backs Minoryx’s ALD therapy while rejecting Zevra’s eczema candidate
The Committee for Medicinal Products for Human Use (CHMP) recommended approval for Minoryx Therapeutics’ ALD drug, while issuing a negative opinion for Zevra Therapeutics’ Meplyffa in Europe. The...
Arrowhead secures strong Phase 3 positioning for Redemplo (plozasiran) label expansion in severe hypertriglyceridemia
Arrowhead Pharmaceuticals reported positive Phase 3 top-line results for plozasiran (Redemplo) in severe hypertriglyceridemia, with the data described as meeting primary and key secondary goals...
Scribe Therapeutics launches and sizes $129M gene-editing IPO to fund PCSK9 and atherosclerosis pipeline
Scribe Therapeutics began a run of 2026 gene-editing IPOs by pricing a $128.7 million offering (upsized from earlier indications) to support in vivo CRISPR-based programs. The gene editor is...
Royalty Pharma expands late-stage cardiology exposure with Neurimmune cliramitug deal
Royalty Pharma agreed to invest $425 million tied to Neurimmune’s cliramitug, a TTR-fibril-depleting antibody aimed at transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The transaction...
Samsung Biologics pushes deeper into peptides with proposed $1.8B PolyPeptide acquisition
Samsung Biologics announced an all-cash tender offer of roughly $1.8 billion to acquire Switzerland-based PolyPeptide Group, a CDMO specializing in peptide-based APIs. The acquisition is designed...
NIH 4D Nucleome program publishes new single-cell multi-omics insights across diseases and aging
The NIH 4D Nucleome program released a new wave of findings focused on how genome organization in space and time influences gene regulation, spanning multiple diseases and human aging biology....
Cell & gene therapy manufacturing grapples with regulatory particulate inspection in opaque, cell-containing products
As cell-containing therapies move toward broader commercialization, manufacturers are updating particulate control and inspection strategies to meet evolving regulatory expectations. Coverage...
Obesity therapeutics – retatrutide moves toward FDA filing
Eli Lilly advanced its triple-G obesity program after new Phase 3 results positioned retatrutide (retatrutide/“reta”) for an FDA filing. The company said additional obesity trial data cleared key...
Genetics IPO – Scribe funds in vivo gene editing for lipid targets
Scribe Therapeutics raised $128.7 million gross in its IPO for in vivo gene editing and pushed the offering to the top of its range. The company’s lead program, STX-1150, is designed to silence...
Royalty financing – Royalty Pharma expands ATTR-CM exposure
Royalty Pharma agreed to buy a $425 million interest tied to Neurimmune’s cliramitug, a TTR-fibril-depleting antibody in Phase 3 for transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The...
FDA advisory committee – broader access for compounded wellness peptides
An FDA advisory committee recommended expanding compounding access for unapproved peptides BPC-157 and KPV, following narrow votes that occurred amid policy controversy over evidence and...
Oncology approval from acquisition – GSK’s Jideytro clears the FDA
GSK’s newly acquired ROS1 inhibitor zidesamtinib (branded Jideytro) won FDA approval for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after prior ROS1 kinase...
Biopharma M&A – Dassault Systèmes buys Arisglobal to unify life-science data
Dassault Systèmes agreed to buy Arisglobal for up to $2 billion, aiming to build a unified AI intelligence platform across life-sciences workflows. The deal combines Arisglobal’s regulatory and...
Peptide manufacturing buildout – Samsung Biologics bids for PolyPeptide
Samsung Biologics made an all-cash tender offer of about $1.8 billion to acquire PolyPeptide Group, a Switzerland-based CDMO focused on peptide APIs. The move expands Samsung’s manufacturing...
Gene editing financing – Transcripta raises for neurological disease programs
Transcripta Bio raised $24 million to advance AI-driven neurological disease therapeutics focused on modulating gene expression signatures. The company says it will use patient-derived single-cell...
Cell and gene therapy manufacturing – QC workarounds for particulates
Manufacturers of cell-containing products are adapting quality-control approaches for visible and sub-visible particulates as regulatory guidance remains unclear for certain inspection workflows....
Bioinformatics/epigenomics – NIH 4D Nucleome expands multi-omics mapping
New findings from the NIH 4D Nucleome program extended spatial epigenomics with body-wide and disease-focused single-cell multi-omics studies, including multi-tissue efforts that map 3D genome...