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Regulatory decisions: FDA gene therapy approval
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning it as the first gene therapy designed to restore a neurosensory function to normal levels....
FDA reconsideration for rejected cell therapy
The FDA agreed to reconsider approval of Pierre Fabre and Atara Biotherapeutics’ twice-rejected Ebvallo (tabelecleucel) after a new meeting with regulators. The companies said the agency accepted...
Corporate IPOs and funding: Odyssey’s public-market debut
Odyssey Therapeutics completed an upsized IPO, raising $304 million gross proceeds to fund autoimmune and inflammatory programs. The company priced 15.5 million shares at $18 and also entered a...
Digital pathology consolidation: Roche to acquire PathAI
Roche agreed to acquire PathAI in a deal valued at up to $1.05 billion to expand its AI-powered diagnostic platform. Roche will pay $750 million upfront and make additional milestone payments of...
Major pharma M&A: Angelini buys Catalyst for rare neurology portfolio
Angelini Pharma will acquire Catalyst Pharmaceuticals in an all-cash deal valued at $4.1 billion, adding a portfolio of FDA-approved rare neurology drugs. The transaction includes Catalyst’s...
Diagnostics and liquid biopsy: Guardant raises guidance on oncology momentum
Guardant Health raised its full-year 2026 guidance after Q1 revenue grew 48% year over year, driven by continued strength in oncology testing and screening. The company reported $301.7 million...
Cell therapy manufacturing innovation: In vivo mRNA LNP platform reprograms T cells
Researchers at the University of Pennsylvania reported an in vivo mRNA-LNP platform capable of selectively reprogramming cytotoxic effector T cells (Teff) by targeting the CX3CR1 marker. The...
Biotech finance: Seed round for manufactured red blood cells
Scarlet Therapeutics closed a $4 million seed round to advance its manufactured red blood cell platform toward a first clinical application. The company said its manufactured RBCs behave similarly...
Diagnostics IP and litigation: 10x Genomics sues Element over spatial patents
10x Genomics sued Element Biosciences, alleging that Element’s Aviti24 multiomic spatial platform infringes multiple 10x spatial technology patents licensed from Harvard University. The complaint...
Biopharma deals: Cell therapy and diagnostics partnerships
Circle Biosciences (Immatics) and Cellular Origins agreed to use Cellular Origins’ automated mobile robotic platform, Constellation, across parts of Immatics’ cell therapy manufacturing workflows....
FDA accelerates gene therapy with first-in-class hearing-loss approval
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning the therapy as the first gene treatment designed to restore neurosensory function in...
FDA reconsiders Ebvallo after initial shock rejection
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics said the FDA agreed to reconsider Ebvallo (tabelecleucel/tab-cel) after the agency previously rejected the therapy for relapsed or refractory...
Biotech IPOs return with heavy immunology and Nasdaq filings
Odyssey Therapeutics priced an upsized IPO and concurrent private placement to fund autoimmune and inflammatory pipeline assets and complete its return to public markets. The company raised $304...
Oncology and diagnostics capital flows: Caris and Guardant operational momentum
Caris Life Sciences took a step to expand access to its blood-based genomic profiling assay by submitting an application to the New York State Department of Health (NYSDOH) for authorization to...
Guardant Health Boosts Guidance on Q1 Growth – Minimal Residual Disease Momentum Continues
Guardant Health reported Q1 2026 revenue of $301.7 million, up 48% year over year, and increased its full-year outlook to $1.30 billion–$1.32 billion. Company executives pointed to volume growth...
Precision diagnostics expansion: TGen launches 3-day whole-genome multiple myeloma test
Translational Genomics Research Institute (TGen), part of City of Hope, launched JAYseq™, a clinical whole-genome sequencing test for multiple myeloma designed to deliver results in about three...
Digital pathology deal accelerates AI-powered diagnostics scale at Roche
Roche agreed to acquire PathAI for up to $1.05 billion to expand its digital pathology capabilities and strengthen AI-powered diagnostic workflows. Under the terms announced, Roche will pay $750...
Patent fight heats up in spatial genomics and prenatal sequencing
10x Genomics sued Element Biosciences, alleging the Aviti24 multiomic spatial platform infringes spatial-technology patents licensed from Harvard University. In its Delaware complaint, 10x cites...
Illumina Takes Action Against BillionToOne on NIPT Patent Claims
Illumina filed a complaint in U.S. District Court for the District of Delaware against BillionToOne, alleging infringement of multiple patents covering non-invasive prenatal testing technologies....
Cell-free DNA fragmentomics gains momentum for tumor detection
Researchers highlighted a cell-free DNA fragmentomics technique designed to detect tumor-linked nucleosomal patterns by analyzing the size distribution of circulating DNA fragments. The approach,...