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FDA clears Kura’s ziftomenib — first menin inhibitor approved for NPM1‑mutant AML
The U.S. FDA approved Kura Oncology and Kyowa Kirin’s ziftomenib (Komzifti) for relapsed or refractory acute myeloid leukemia with NPM1 mutations, granting the drug full approval based largely on...
Multi‑omics of pig‑to‑human kidney transplant reveals immune drivers — rejection reversible
Researchers published comprehensive multi‑omic analyses following a gene‑edited pig kidney transplanted into a brain‑dead human recipient and tracked immune responses over 61 days. Teams...
Medicxi closes €500M fund V to back asset‑centric biotech creation
London‑based venture firm Medicxi raised €500 million for Fund V to finance asset‑centric biotech startups and selective later‑stage opportunities. The oversubscribed fund continues Medicxi’s...
Novartis’ GanLum meets Phase III goal — a new tool against resistant malaria
Novartis reported Phase III non‑inferiority results for GanLum (ganaplacide + lumefantrine), meeting WHO efficacy thresholds and showing high cure rates across study arms in sub‑Saharan Africa....
Magnetically guided microrobots pass large‑animal tests for targeted delivery
Researchers at ETH Zurich described a magnetically guided microrobotic platform that navigates vasculature and cerebrospinal spaces in large‑animal models to deliver localized drug payloads. The...
Ultra‑mild methylation sequencing overcomes DNA damage limits in archival samples
Researchers unveiled UMBS‑seq (Ultra‑Mild Bisulfite Sequencing), a gentler methylation assay that preserves degraded DNA while delivering accurate methylation calls—addressing long‑standing...
Biotech shakeups: layoffs, pivots and cash‑preserving restructurings hit small firms
Sensei Therapeutics announced a 65% workforce reduction and termination of three executive roles as it winds down development and explores strategic alternatives; the company retains a minimal...
Merck pays $9.2B for Cidara: bets on season-long flu biologic
Merck agreed to acquire Cidara Therapeutics for $9.2 billion in cash, securing rights to CD388, a late‑stage long‑acting antiviral designed to prevent seasonal influenza. The deal values Cidara at...
FDA clears Kura/Kyowa’s Komzifti — first menin inhibitor approved for NPM1 AML
The U.S. Food and Drug Administration approved ziftomenib (Komzifti), a selective oral menin inhibitor developed by Kura Oncology and Kyowa Kirin, for relapsed or refractory acute myeloid leukemia...
FDA unveils plausible‑mechanism pathway: roadmap for bespoke rare‑disease therapies
Top FDA officials outlined a new regulatory approach — dubbed the "plausible‑mechanism" or bespoke pathway — to accelerate approvals for individualized gene‑editing and personalized biologics when...
Multi‑omics maps rejection in pig‑to‑human kidney grafts — 61‑day physiology study
Researchers published comprehensive multi‑omic analyses following a genetically modified pig kidney transplanted into a brain‑dead human recipient and maintained for 61 days. Teams tracked tissue,...
Pfizer closes up to $10B Metsera deal — inside a high‑stakes bidding war
Pfizer completed its acquisition of obesity biotech Metsera for up to $10 billion, securing the company’s fast‑acting amylin analog and long‑acting GLP‑1 assets. The purchase ends a heated contest...
Novartis’ GanLum clears Phase 3: new antimalarial meets WHO efficacy bar
Novartis reported that GanLum, a combination including ganaplacide, met its primary endpoint in a large Phase 3 trial across sub‑Saharan Africa and achieved cure rates that meet or exceed WHO...
Medicxi secures €500M fund — pours cash into asset‑centric biotech creation
London‑based venture firm Medicxi closed a €500 million (about $581 million) Fund V to back asset‑centric biotech startups and opportunistic later‑stage investments. The oversubscribed vehicle...
Magnetic microrobots navigate vasculature: in vivo delivery shown in large animals
Teams at ETH Zurich reported a clinically‑oriented microrobotics platform that uses electromagnetic navigation to steer dissolvable, drug‑loaded microrobots through complex vasculature and...
BMS–J&J’s next‑gen blood thinner fails phase 3 — milvexian study stopped for futility
Bristol Myers Squibb and Johnson & Johnson suspended a Phase 3 trial of milvexian, a selective factor XIa inhibitor intended as a next‑generation anticoagulant, after an interim analysis showed...
Lilly bets $2.6B on ABL Bio’s Grabody: brain‑shuttle licensing pact
Eli Lilly struck a licensing and research agreement with ABL Bio worth up to $2.6 billion to develop therapeutics using the Grabody‑B blood‑brain barrier (BBB) penetration platform. ABL will...
FDA clears Komzifti: Kura, Kyowa secure first menin inhibitor approval in NPM1 AML
The U.S. Food and Drug Administration approved ziftomenib (Komzifti) from Kura Oncology and Kyowa Kirin for relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation. The decision was...
Pfizer closes Metsera deal: obesity biotech absorbed after heated bidding
Pfizer finalized a takeover of obesity biotech Metsera in a deal worth up to $10 billion, ending a contentious bidding battle with Novo Nordisk. The acquisition gives Pfizer access to Metsera’s...
Multi-omics map immune triggers: pig‑to‑human kidney xenotransplant reveals rejection pathways
Teams published comprehensive multi‑omic analyses following a gene‑edited pig kidney transplanted into a brain‑dead human decedent and monitored for 61 days. Studies in Nature traced immune...