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Ribo and Madrigal team up: $60M upfront to push siRNA portfolio in MASH
Suzhou Ribo Life Science and Madrigal Pharmaceuticals agreed a global licensing deal to develop six preclinical siRNA programs targeting metabolic dysfunction‑associated steatohepatitis (MASH)....
Quantx raises $85M to advance oral immunology candidates
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two lead oral immunology programs: a STAT6 small‑molecule inhibitor and an IL‑17 oral inhibitor. The financing positions...
CareDx readies AlloHeme launch after validation shows early relapse lead time
CareDx reported validation data for AlloHeme, its cell‑free DNA sequencing assay for allogeneic hematopoietic cell transplant (HCT) surveillance, demonstrating 85% sensitivity and 92% specificity...
All of Us hits 1 million: NIH milestone expands precision‑medicine resource
NIH’s All of Us research program announced it has reached its goal of collecting genetic and health data from 1 million Americans representative of the country’s diversity. The cohort includes...
World‑first pediatric mRNA brain‑cancer trial launches in Australia
Australia has started the Paedneo‑Vax trial, the first multisite pediatric study to evaluate individualized mRNA vaccines tailored to each child’s brain tumor. Funded by Providence Therapeutics...
Inhaled gene therapy shows early promise in lung cancer delivery
Researchers reported early results from the first inhalable gene‑therapy program for lung cancer, demonstrating feasibility of delivering therapeutic nucleic acids via aerosolized formulations....
FDA refuses to review Moderna flu shot — company says letter blindsided team
The FDA issued a refusal-to-file for Moderna’s next-generation mRNA influenza vaccine, stopping the agency from even beginning a formal review. Moderna’s executives, including President Stephen...
NIAID told to drop 'biodefense' and 'pandemic preparedness' — agency shifts funding focus
Senior NIH leadership instructed the National Institute of Allergy and Infectious Diseases (NIAID) to remove the terms “biodefense” and “pandemic preparedness” from its website and to reprioritize...
BridgeBio’s oral FGFR3 inhibitor posts Phase 3 win — files planned this year
BridgeBio reported positive top-line results from its global Phase 3 Propel 3 trial of infigratinib in children with achondroplasia, the most common genetic form of dwarfism. The oral FGFR3...
PTC withdraws US approval bid for Translarna — FDA doubts clinical benefit
PTC Therapeutics withdrew its U.S. filing for Translarna (ataluren) after the FDA signaled the submitted data were unlikely to meet the agency’s standard for substantial evidence of effectiveness...
Ultragenyx cuts 10% of workforce as FDA presses on gene therapy review
Ultragenyx announced a workforce reduction of about 130 people (roughly 10%) amid restructuring intended to reach profitability by 2027. The company reported that the FDA again delayed approval...
Lyell starts first head-to-head CAR‑T trial... testing new cell therapy against market leaders
Lyell Immunopharma initiated a first-of-its-kind randomized trial that will compare its experimental CAR‑T therapy directly against established marketed CAR‑T products. The head-to-head design...
Quantx raises $85M to advance oral STAT6 and IL‑17 programs
Quantx Biosciences closed an $85 million Series B to finance IND-enabling work and early clinical trials for two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The raise,...
CareDx’s AlloHeme shows high sensitivity, 41‑day lead time — commercial launch planned
CareDx reported validation data from the ACROBAT observational study showing its AlloHeme cell‑free DNA assay detected mixed chimerism and relapse signals in allogeneic hematopoietic cell...
European VCs form coalition — new push to keep biotech funding and exits in the EU
Leading European life‑science investors including Forbion, Novo Holdings and Sofinnova launched the European Life Science Coalition to mobilize private and public capital for the region’s biotech...
Gilead buys global rights to Genhouse oral cancer drug — $80M upfront
Gilead Sciences acquired global rights to an oral oncology candidate from China‑based Genhouse Bio for $80 million upfront, expanding Gilead’s small‑molecule oncology footprint. The deal follows...
FDA refusal halts Moderna flu review — mRNA vaccine program in limbo
The FDA issued a refusal-to-file for Moderna’s mRNA influenza vaccine, prompting an immediate public dispute between the company and regulators. Moderna said the agency’s letter cited procedural...
BridgeBio’s oral drug boosts growth in children — Phase 3 win sets up FDA filing
BridgeBio announced positive top-line results from Propel 3: oral infigratinib produced a statistically significant increase in annualized height velocity in children with achondroplasia. The...
Ultragenyx cuts 10% as late‑stage failures force restructuring — gene therapy review stalled
Ultragenyx disclosed a strategic restructuring that includes laying off roughly 10% of staff after a year of disappointing late‑stage trial results. The company reported that two brittle bone...
FDA removes black‑box warnings from six menopausal therapies — labeling overhaul
The FDA removed the most severe 'black box' warnings related to breast cancer, cardiovascular disease and dementia from labeling for six hormone replacement therapies used in menopause....