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Endometriosis diagnostics mature — new tests and UK tissue‑model startup raise funds
A wave of noninvasive endometriosis tests is approaching U.S. launch, with companies analyzing biomarkers in endometrial tissue, blood, menstrual fluid and saliva to shorten a diagnosis that today...
AI‑driven 3D cell analysis platforms take center stage — HCS‑3DX and capsule tech
Researchers unveiled HCS‑3DX, an AI‑driven high‑content screening platform for automated analysis of 3D multicellular structures such as spheroids and organoids, promising to speed drug discovery...
Epigenetic edits in T cells: multiplex platform advances CAR‑T engineering
Researchers reported a new epigenetic editing platform that enables simultaneous reprogramming of multiple genes in primary human T cells, creating enhanced cellular therapies for cancer. Teams at...
Grail raises cash — ctDNA test multiplies early cancer detection
Grail announced a $325 million private placement to fund commercial expansion and reimbursement efforts for its Galleri circulating tumor DNA (ctDNA) test. The financing, disclosed by Grail,...
Replimune resubmission accepted — FDA sets new review clock
Replimune resubmitted its biologics license application for RP1, an engineered oncolytic herpes simplex virus given with PD‑1 blockade, and the FDA has accepted the filing and set a target...
Exelixis to file NDA after STELLAR‑303 OS gain — regulators next
Exelixis plans an NDA submission for zanzalintinib after presenting mature overall‑survival data from the Phase 3 STELLAR‑303 trial showing a survival benefit when the TKI was combined with...
ADCs at ESMO — combination regimens push into earlier settings
Antibody–drug conjugates (ADCs) dominated several high‑profile sessions at ESMO, with multiple companies reporting combination strategies that pair ADCs with PD‑1 inhibitors or chemotherapies to...
mRNA vaccines boost checkpoint efficacy — clinical signals at ESMO
Data presented at ESMO and MD Anderson analyses indicate that administration of mRNA COVID‑19 vaccines near the time of starting checkpoint inhibitors correlates with improved survival in some...
AI platforms for drug discovery: Anthropic and Genomics roll out life‑science tools
Anthropic launched Claude for Life Sciences, a purpose‑built large language model with integrations for scientific workflows and partnerships with 10x Genomics and Benchling to interrogate...
Roche gains FDA nod for Gazyva — new biologic enters lupus nephritis market
The FDA approved Roche’s CD20 antibody Gazyva for treatment of lupus nephritis, expanding the drug’s label beyond oncology and providing an alternative biologic for patients with autoimmune kidney...
JAX acquires NYSCF — scale-up bet on stem cells and precision therapies
The Jackson Laboratory completed acquisition of the New York Stem Cell Foundation, creating a combined academic‑industrial research platform aimed at accelerating translational stem‑cell science...
Regulatory strain: FDA staffing losses and CBO flags orphan‑drug cost impact
New agency data show historic departures from the FDA’s drug and biologics centers, with nearly 1,000 net exits in the last quarter of fiscal 2025. The staffing shortfall raises operational and...
FDA accepts Replimune resubmission — April action date set
The FDA has accepted Replimune’s resubmitted biologics license application for RP1, the company said, setting an April 10, 2026 target date for a decision. Replimune added new analyses and...
Roche’s Gazyva wins FDA nod for lupus nephritis
The FDA expanded approval for Roche’s CD20-targeting antibody Gazyva to include lupus nephritis, the company announced. Gazyva was previously approved in oncology and now gains a new autoimmune...
Exelixis plans NDA after Phase 3 survival gain — shares slip on mixed reaction
Exelixis said it will file a US NDA for zanzalintinib after detailed Phase 3 Stellar‑303 results showed an overall survival benefit when combined with atezolizumab versus regorafenib in previously...
ADCs take center stage at ESMO — combos and new generations advance
Antibody‑drug conjugates (ADCs) dominated ESMO 2025 sessions, with presentations showing activity across urothelial, breast and ovarian cancers and renewed emphasis on combination regimens....
Grail raises $325M and touts ctDNA boost to screening yields
Grail announced a roughly $325 million private placement to fund commercial expansion, reimbursement efforts and working capital, alongside recent data showing its Galleri circulating tumor DNA...
Anthropic, Genomics roll out life‑science LLMs and platforms
Anthropic launched Claude for Life Sciences and announced collaborations with 10x Genomics and Benchling to enable natural‑language interrogation of single‑cell and other datasets. The product...
UCSD’s AI‑driven CANDiT and precision reprogramming target cancer stem cells
Researchers at UC San Diego published CANDiT, a machine‑learning systems‑biology framework that identifies differentiation therapy targets to reprogram cancer stem cells (CSCs) and trigger...
Summit and partners press ivonescimab toward pivotal testing after China win
Summit Therapeutics and partners reported ivonescimab, a PD‑1xVEGF bispecific, cut progression or death by 40% versus a PD‑1 in a Chinese first‑line lung cancer trial; companies aim to start Phase...