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FDA clears Kura’s menin inhibitor – new option for NPM1‑mutant AML
The U.S. Food and Drug Administration approved Kura Oncology and Kyowa Kirin’s oral menin inhibitor ziftomenib (Komzifti) for relapsed or refractory acute myeloid leukemia (AML) with NPM1...
Pig kidney xenotransplant mapped: multi‑omics traces rejection and rescue
Researchers performed a pig‑to‑human kidney xenotransplant into a brain‑dead recipient and ran comprehensive multi‑omics and physiological monitoring over 61 days, revealing the immune dynamics...
FDA tightens Sarepta’s Elevidys label – boxed warning and use limits
The FDA revised the prescribing information for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys to include a boxed safety warning and to limit use to ambulatory patients,...
EMA advisers back five products – charity‑led gene therapy clears EU hurdle
The European Medicines Agency’s CHMP recommended five new medicinal products, including Fondazione Telethon’s ex‑vivo gene therapy Waskyra (etuvetidigene autotemcel) for Wiskott‑Aldrich syndrome....
Day One acquires Mersana – backloaded deal centers on B7‑H4 ADC
Day One Biopharmaceuticals agreed to acquire Mersana Therapeutics, paying $129 million upfront and up to $285 million including milestones, in a backloaded deal focused on Mersana’s...
DeepTarget and AI safety models: computational tools reshape drug discovery
Researchers unveiled DeepTarget, a computational platform that predicts mechanisms of action for small molecules, and separate work from Cellarity described an AI‑driven framework for predicting...
CIRM funds embryo‑formation work – ethics debate intensifies in Japan
The Terasaki Institute and Caltech won a $2.8 million Discovery Stage Research grant from the California Institute for Regenerative Medicine to study early human embryo formation using stem‑cell...
Merck stakes $9.2B on Cidara: buys late‑stage flu asset
Merck agreed to buy Cidara Therapeutics for about $9.2 billion to acquire CD‑388, a late‑stage, long‑acting antiviral being developed as a season‑long prophylactic against influenza. The deal,...
Pfizer seals Metsera deal: ends $10B bidding war
Pfizer completed its acquisition of Metsera in a transaction worth up to $10 billion, closing a high‑profile bidding contest with Novo Nordisk. The deal secures Metsera’s obesity portfolio...
Lundbeck interrupts Alkermes’ Avadel deal: offers higher bid
Lundbeck submitted an unsolicited, higher cash-and‑contingent bid for Avadel Pharmaceuticals, challenging Alkermes’ previously announced $2.1 billion acquisition. Lundbeck’s proposal raises the...
FDA tightens gene therapy safety; AMP issues draft cancer‑NGS rules
The U.S. FDA revised the label for Sarepta’s Duchenne gene therapy Elevidys, adding a boxed safety warning and narrowing its use to ambulatory patients while requesting postmarketing study...
Multi‑omics maps immune rejection in pig‑to‑human kidney graft
Two independent multi‑omics reports traced immune responses after a genetically modified pig kidney was transplanted into a brain‑dead human recipient and maintained for 61 days. Teams collected...
FDA clears Komzifti for r/r NPM1‑mutant AML: ziftomenib approved
The FDA approved ziftomenib (Komzifti), a selective oral menin inhibitor from Kura Oncology and Kyowa Kirin, to treat relapsed or refractory NPM1‑mutant acute myeloid leukemia. Approval was based...
ML model predicts donor death timing – cuts futile liver procurements 60%
Stanford Medicine researchers developed and validated a machine‑learning model that predicts whether donation‑after‑circulatory‑death (DCD) donors will die within the timeframe needed for viable...
Non‑GM immortalization of bovine cells opens path for scalable cultivated beef
Scientists at Hebrew University and Believer Meats reported a Nature study demonstrating a non‑genetically modified method to induce stable self‑renewal in bovine cells by activating telomerase...
DeepTarget: AI predicts anti‑cancer drug mechanisms of action
Researchers at Sanford Burnham Prebys unveiled DeepTarget, a machine‑learning platform published in npj Precision Oncology that predicts anti‑cancer mechanisms of small molecules by integrating...
AMP 2025 spotlights next‑gen blood cancer diagnostics; AI tools front and center
At AMP 2025, researchers unveiled advances in blood cancer diagnostics and placed AI‑driven pathology front and center. Presentations showcased highly sensitive ctDNA NGS panels for AML/other...
Merck pays $9.2B for Cidara’s long‑acting flu biologic
Merck agreed to acquire Cidara Therapeutics for $9.2 billion to secure CD388, a late‑stage, long‑acting antiviral designed to prevent seasonal influenza. The deal, announced Friday, values Cidara...
Pfizer closes up to $10B Metsera buy — fast‑acting obesity assets onboarded
Pfizer completed its acquisition of Metsera in a deal worth up to $10 billion, securing fast‑acting amylin and long‑acting GLP‑1 assets aimed at the obesity market. The transaction ends a heated...
FDA adds boxed warning to Sarepta’s Elevidys: ambulatory use restricted
The U.S. Food and Drug Administration updated the label for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys to include a boxed safety warning and to limit use to ambulatory...