Get the Daily Brief
Latest Biotech News
Regulatory decision reroutes for gene therapy approvals
The FDA agreed to reconsider an approval path for Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ EBV-specific T-cell therapy Ebvallo (tabelecleucel), following the agency’s earlier shock...
New FDA authorization for a first-in-class hearing gene therapy
Regeneron won accelerated approval from the FDA for Otarmeni (lunsotogene parvec-cwha), described as the first gene therapy to restore neurosensory function for OTOF-associated sensorineural...
Oncology trial readout moves in unknown primary cancer
Researchers reported phase II results for a combination intended to treat cancers of unknown primary (CUP) with a regimen that pairs an anti-PD-1 immune checkpoint inhibitor with nab-paclitaxel....
New clinical enrollment for pancreatic cancer diagnostic utility
Amplified Sciences started patient enrollment for PanAMP, a multicenter real-world clinical utility study assessing how its PanCystPro assay influences clinical decision-making for early...
Caris expands access to genomic profiling testing through New York review
Caris Life Sciences submitted an application to New York State Department of Health’s Clinical Laboratory Evaluation Program to authorize Caris Assure for specimens originating in the state. The...
Precision diagnostics demand lifts major liquid biopsy player guidance
Guardant Health reported strong Q1 2026 revenue growth and raised full-year guidance after oncology testing volumes and minimal residual disease (MRD) demand accelerated. The company posted Q1...
Biotech IPOs raise cash to fund autoimmune and cell therapy pipelines
Odyssey Therapeutics returned to the public markets with an upsized IPO and concurrent private placement, bringing $304 million in gross proceeds to fund its autoimmune and inflammatory pipeline....
M&A and platform bets in digital pathology
Roche agreed to acquire PathAI in a deal valued at up to $1.05 billion to expand its digital pathology and companion diagnostics capabilities. Roche will pay $750 million upfront, with as much as...
Spatial genomics patent dispute escalates
10x Genomics sued Element Biosciences, alleging Element’s Aviti24 multiomic platform infringes 10x spatial technology patents licensed from Harvard University. The complaint was filed in the US...
Cell-free DNA fragmentomics moves into tumor-linked pattern detection
Researchers reported a fragmentomics approach designed to detect tumor-linked nucleosomal patterns by analyzing size distributions of circulating cell-free DNA. The technique connects fragment...
Gene therapy approval
The FDA granted accelerated approval to Regeneron’s in vivo gene therapy Otarmeni (lunsotogene parvec-cwha), making it the first gene therapy designed to restore neurosensory function in...
Regulatory reconsideration for cell therapy
The FDA agreed to reconsider Ebvallo (tabelecleucel) after a surprise rejection earlier in 2026, giving Pierre Fabre Pharmaceuticals and Atara Biotherapeutics a new potential path toward review....
Big pharma M&A and portfolio expansion
Bayer agreed to acquire Perfuse Therapeutics for up to $2.45 billion, seeking to expand its ophthalmology pipeline beyond its current Eylea franchise. The deal adds full rights to PER-001, a...
AI-driven digital pathology consolidation
Roche agreed to acquire PathAI in a transaction valued at up to $1.05 billion to strengthen its digital pathology capabilities and expand AI-enabled diagnostic workflows. Roche will pay $750...
Immunology startup IPO financing
Odyssey Therapeutics raised $304 million through an upsized IPO and concurrent private placement, putting fresh capital behind its ulcerative colitis program and expanding its autoimmune pipeline....
Seed funding for mRNA platform
ParcelBio secured $13 million in seed financing to develop its APEXm (Amplified and Prolonged EXpression mRNA) platform and advance an in vivo CAR T program for autoimmune disease. The round was...
Antibody-drug conjugate IND clearance
Arrivent Biopharma received FDA IND clearance for ARR-002 (AV-P138-ADC), an antibody-drug conjugate aimed initially at ovarian and endometrial cancers, with broader potential across solid tumors....
Cell-free DNA diagnostics method
Researchers unveiled a cell-free DNA fragmentomics approach that decodes tumor-linked nucleosomal patterns by analyzing the size distribution of circulating cfDNA fragments. The method links...
Company litigation in spatial omics patents
10x Genomics sued Element Biosciences, alleging that Element’s Aviti24 multiomic analysis platform infringes spatial technology patents licensed from Harvard University. The complaint, filed in...
Financial results and guidance update
Guardant Health reported Q1 2026 revenue growth of 48% year over year, driven by increases in both minimal residual disease (MRD) testing and broader oncology and screening activity. The company...