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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...
Jackson Laboratory acquires NYSCF to scale stem‑cell research and therapies
The Jackson Laboratory completed acquisition of the New York Stem Cell Foundation to create an integrated research and translational platform, the institutions said. The deal combines JAX’s...
CBO revises orphan‑drug cost estimates upward after new law; industry windfalls flagged
The Congressional Budget Office (CBO) reported unexpected fiscal impacts from the Orphan Cures Act, raising a ten‑year cost estimate as three drugs drove larger‑than‑expected effects on price...
FDA Accepts Replimune Resubmission: April 10 Review Set
Replimune resubmitted its biologics license application for RP1, an engineered oncolytic herpes simplex virus combined with PD-1 blockade, and the FDA has accepted the filing with a target...
Grail Raises $325M; Galleri Shows Sevenfold Detection Gain
Grail entered a securities purchase agreement to raise approximately $325 million to fund commercial expansion and reimbursement efforts for its Galleri multi-cancer early-detection test. New and...
Exelixis Readies NDA After OS Win: Zanzalintinib Data Revealed
Exelixis said it will pursue a New Drug Application following Phase 3 STELLAR-303 results showing its oral TKI zanzalintinib plus atezolizumab reduced risk of death by about 20% versus regorafenib...
FDA Expands Gazyva Label: New Biologic Option for Lupus Nephritis
The FDA granted Roche an additional indication for Gazyva (obinutuzumab), approving the CD20-targeting antibody for treatment of lupus nephritis. The approval expands the agent's use beyond...
Anthropic Debuts Claude for Life Sciences: Industry Partnerships Signed
Anthropic launched Claude for Life Sciences, a domain-specialized large language model designed to assist researchers with tasks ranging from literature synthesis to querying complex datasets. The...