Current Editions

China’s approval of CARsgen’s satri-cel gives CAR T its first solid tumor foothold, and a new calculus for its cost, complexity, and safety

WHO prioritizes Zaire-tested mAbs, antivirals as academic labs seek path for strain-specific, pan-Ebolavirus therapies

Flagship’s Expedition is training AI on proteome-wide reactivity data and quantum chemistry to design covalent small molecules

Halfway through the year, at least 13 West-based companies have launched with Asian assets, nearly matching 2025’s full-year total

BioCentury’s Distillery highlights organoids, assembloids, and engineered neurons modeling CNS disease across circuits, time, and vulnerable cells

Some actions are already complete, but the biggest changes to IND review, IRBs and trial enrollment remain ahead

The U.S. roadmap could speed trial starts, but China retains advantages in parallel review, faster IND pathways, and regulatory flexibility

Replimune and Capricor meetings revisit Prasad-era controversies, while peptide review will test MAHA’s influence over FDA

At least 11 products derailed under Makary, Prasad, Høeg are back on track as if they hadn't happened

Recommendation to revoke EU authorization follows FDA withdrawal proposal, with both agencies citing data integrity concerns

FDA approval moves Tryngolza from rare FCS into severe hypertriglyceridemia, giving Ionis its first shot at a broad cardiometabolic market

FTC brief argues J&J's acquisition of Momenta's patents broke antitrust law if it harmed competition — regardless of what J&J intended

Takeout adds long-acting atopic dermatitis therapy, headed into Phase III, that could compete with Dupixent and Ebglyss

Plus: Patient Square backs Osanni’s hub-and-spoke model; Nura moves ahead in neurodegeneration; and a handful of NewCos draw cash

Plus: uniQure, MoonLake and Taysha round out group raising nearly $1.5B combined