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FDA clears new oral options for gonorrhea — treatment landscape widens
Regulators added two oral antibiotics to the gonorrhea treatment toolbox: Innoviva’s zoliflodacin (Nuzolvence) and GSK’s gepotidacin (Blujepa) secured approvals/label expansions as supplemental...
Natera buys Foresight, expands MRD and hematology push
Natera agreed to acquire Foresight Diagnostics for about $275 million to gain phased‑variant enrichment and detection sequencing technology aimed at improving minimal residual disease (MRD)...
Illumina backs MyOme trial — WGS plus AI to test population‑scale risk prediction
Illumina made a strategic investment in MyOme and will support a prospective clinical trial that pairs whole‑genome sequencing with MyOme’s AI risk models. MyOme said the Proactive Health trial...
Parse, Tahoe to sequence 300M cells — building an AI‑trained perturbation atlas
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300 million‑cell single‑cell perturbation atlas to train artificial‑intelligence models. Parse will produce the...
House passes BIO‑backed INVEST Act — capital access bill for small biotech clears floor
The U.S. House of Representatives passed the INVEST Act, a bipartisan package aimed at expanding access to capital for small and emerging biotechnology firms by loosening certain regulatory...
Gene-edited cell transplant restores insulin production in type 1 patient
Scientists have transplanted gene-edited, insulin-producing cells into a man with type 1 diabetes and documented endogenous insulin production without the need for chronic immunosuppression. The...
Lilly’s triple-agonist posts record weight loss — safety caveats emerge
Eli Lilly’s experimental triple-agonist retatrutide produced some of the largest weight-loss results reported in late-stage obesity trials, with high-dose arms showing average reductions near the...
Arcus, Gilead’s anti‑TIGIT program fails — company shutters trials and pivots
Arcus Biosciences and partner Gilead disclosed a Phase 3 futility finding for domvanalimab, an anti‑TIGIT antibody, in an upper‑gastrointestinal cancer study; an independent data monitoring...
FDA weighing black‑box warning for Covid shots — experts push back
Reports indicate the FDA is considering adding boxed (black‑box) warnings to Covid‑19 vaccine labeling; the move is being driven within the agency’s biologics branch and has ignited criticism from...
Natera doubles down on ctDNA — acquisition and trial collaborations aim to boost sensitivity
Natera moved to expand its circulating tumor DNA capabilities by acquiring Foresight Diagnostics to integrate PhaseED‑seq phased‑variant technology and by collaborating with MEDSIR on the...
Illumina backs MyOme — investment and collaboration to test genome‑scale PRS utility
MyOme secured strategic backing from Illumina to launch a prospective trial (MPH) combining whole‑genome sequencing and AI‑driven polygenic risk scores to evaluate clinical and economic value at a...
AC Immune posts biomarker gains in Parkinson’s vaccine program
AC Immune reported biomarker results from its Phase II Vacsyn program showing biomarker shifts consistent with reduced alpha‑synuclein pathology and neuronal injury in early Parkinson’s disease....
EMA’s CHMP signals nods and rejections — multiple drug recommendations in December meeting
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a slate of recommendations including backing new medicines from Hansoh and Cytokinetics and recommending ImmunityBio’s Anktiva...
House passes INVEST Act — lawmakers expand capital access for small biotech
The U.S. House approved the bipartisan INVEST Act to ease regulatory barriers and expand capital access for small innovative firms, a move endorsed by the Biotechnology Innovation Organization and...
Parse and Tahoe to build 300M‑cell perturbation atlas to train biology AI
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300‑million‑cell perturbation single‑cell atlas to train AI models for drug discovery and virtual cell modeling....
Gene-edited cell transplant restores insulin — first patient makes insulin without immunosuppression
Scientists have implanted gene-edited, insulin-producing cells into a man with type 1 diabetes and reported restoration of endogenous insulin production without long-term immunosuppressive...
Arcus shutters TIGIT program after Phase III futility — company refocuses R&D
Arcus Biosciences and partner Gilead halted Phase III work on their anti‑TIGIT antibody domvanalimab after independent data monitoring committees flagged futility in upper gastrointestinal...
FDA eyes boxed warning on COVID vaccines — experts warn of unprecedented move
Reports indicate the U.S. Food and Drug Administration is weighing a boxed (black‑box) warning for COVID‑19 vaccines, a regulatory step that outside experts say would be unprecedented for broadly...
AC Immune posts biomarker wins in Parkinson’s vaccine — regulator talks planned
AC Immune released interim biomarker and safety data from its Phase II Vacsyn program targeting alpha‑synuclein in early Parkinson’s disease and reported signals consistent with potential disease...
Lilly’s triple agonist smashes weight‑loss records — tolerability concerns temper excitement
Eli Lilly’s investigational triple‑agonist retatrutide delivered record weight‑loss results in Phase III testing, with the high‑dose cohort losing an average nearing 29% body weight at 68 weeks,...