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Abbott closes Exact Sciences deal: $23B acquisition to expand diagnostics
Abbott announced it will close its $23 billion acquisition of Exact Sciences after receiving all regulatory clearances, moving to integrate colorectal and cancer‑related screening assets into its...
FDA demands sham arm for Huntington’s gene therapy: uniQure faces new trial hurdle
The U.S. Food and Drug Administration told uniQure it expects a prospective, randomized, double‑blind, sham‑surgery‑controlled study to support marketing approval for AMT‑130, the company’s...
Muscle drug setbacks: Roche and Genentech halt programs after negative efficacy
Roche said it will stop development of emugrobart after clinical studies showed the drug failed to consistently improve muscle growth and motor function. Separately, Genentech moved to discontinue...
Tumor whole‑genome sequencing shows clinical value: 888‑patient real‑world study
A real‑world analysis of 888 patients demonstrated that paired tumor‑normal whole‑genome sequencing (WGS) can yield actionable biomarkers across a broad range of solid cancers, the study reported....
Lab‑grown esophagus restores swallowing in pigs — pediatric grafts on horizon
Scientists at Great Ormond Street Hospital and University College London engineered and implanted an autologous, decellularized porcine esophageal graft repopulated with recipient cells that...
FDA expands Imcivree use: acquired hypothalamic obesity cleared
The FDA widened the labeled indication for Rhythm Pharmaceuticals’ Imcivree to include adults and children aged four and older with acquired hypothalamic obesity. The regulator’s approval follows...
AI clinical support improves stroke care: cluster trial shows outcome gains
A cluster‑randomized clinical trial published in The BMJ found that an AI‑driven clinical decision support system (CDSS) significantly improved quality of care and long‑term outcomes for acute...
FDA clears four NMEs: approvals reach 26 in first two months of 2026
The U.S. FDA approved four new molecular entities (NMEs), bringing the year‑to‑date total to 26 approvals across January and February. The regulator’s early momentum aligns with historical ranges...
Novartis pays $2 billion upfront for Synnovation PI3Kα asset — Deal secures next‑gen breast cancer candidate
Novartis announced a deal to acquire a Synnovation unit for $2 billion up front to secure SNV4818, a mutant‑selective PI3Kα inhibitor intended for HR+/HER2‑ breast cancer. The acquisition gives...
Earendil Labs raises $787M to scale AI‑driven biologics R&D — Backing from Dimension, Luminous, Sanofi
AI‑powered biotech Earendil Labs secured $787 million in private financing to accelerate a sprawling biologics pipeline and build an R&D organization across the U.S. and China. Investors named in...
Abbott closes Exact Sciences deal Monday — $23B buy adds cancer‑screening and diagnostics assets
Abbott confirmed that its $23 billion acquisition of Exact Sciences has cleared regulatory hurdles and is set to close, bringing Cologuard, Oncotype DX and other cancer‑screening and diagnostic...
FDA insists on sham‑surgery control for uniQure’s Huntington’s gene therapy — Regulators question external controls
The US Food and Drug Administration told uniQure it requires a prospective, randomized, double‑blind, sham surgery‑controlled study to support approval of AMT‑130, the AAV‑based Huntington’s...
Roche halts development of experimental SMA drug emugrobart — Patient letter cites insufficient benefit
Roche informed European patients that it will discontinue development of emugrobart after studies failed to show consistent improvements in muscle growth and motor function. The decision affects a...
Tumor whole‑genome sequencing shows real‑world clinical utility — 888‑patient Nature Medicine study
A Nature Medicine report on 888 patients demonstrated that routine paired tumor‑normal whole‑genome sequencing (WGS) is feasible in clinical oncology and yields actionable results. WGS succeeded...
Lab‑grown esophagus functions in growing pigs — GOSH/UCL report advances pediatric regeneration
Researchers from Great Ormond Street Hospital and University College London reported in Nature Biotechnology the successful engineering, implantation and functional integration of an autologous,...
Startup pays women for menstrual stem‑cell donations — Muse Bio targets regenerative and fertility markets
SF startup Muse Bio is recruiting menstrual blood donors with $40 payments to build a biobank of menstrual‑derived stem cells (MenSCs) for cosmetics, regenerative medicine and fertility...
FDA expands Rhythm’s Imcivree to acquired hypothalamic obesity — First drug for the rare condition
The FDA widened the label for Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to include acquired hypothalamic obesity in adults and children aged four and older. Clinical trials showed Imcivree...
AI clinical decision support improves stroke care and outcomes — Cluster‑randomized BMJ trial in China
A cluster‑randomized clinical trial published in The BMJ found that an AI‑driven clinical decision support system (CDSS) significantly improved care quality and long‑term outcomes in acute...
Novartis pays $2B for PI3Kα inhibitor: Bolsters breast‑cancer arsenal
Novartis agreed to acquire a Synnovation unit and pay $2 billion upfront to secure SNV4818, a next‑generation PI3Kα inhibitor that selectively targets mutant PI3Kα. The asset, in early clinical...
Earendil raises $787M: AI biologics developer scales pipeline
Earendil Labs closed a $787 million financing to advance an AI‑driven biologics pipeline spanning autoimmune and oncology programs. The round included Dimension, Luminous Ventures and Sanofi among...