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FDA drops boxed warnings for six HRTs — labels narrowed
The FDA removed the most severe boxed warnings relating to breast cancer, cardiovascular disease and probable dementia from six menopausal hormone replacement therapies after an agency review and...
Lyell launches head‑to‑head CAR‑T trial against marketed therapies
Lyell Immunopharma has initiated a first‑of‑its‑kind trial that directly compares its experimental CAR‑T therapy with existing marketed CAR‑T products. The study design pits Lyell’s engineered...
CareDx plans AlloHeme launch after validation shows 41‑day relapse lead
CareDx said validation data from the ACROBAT observational study support commercialization plans for AlloHeme, its cell‑free DNA assay for allogeneic hematopoietic cell transplant surveillance....
Quantx secures $85M to advance oral immunology pipeline
Quantx Biosciences closed an $85 million Series B to advance two oral immunology candidates: a STAT6 small‑molecule inhibitor and an IL‑17 oral inhibitor. The oversubscribed financing funds...
PacBio posts 14% Q4 growth — clinical and European demand climbs
Pacific Biosciences reported a 14% year‑over‑year revenue increase in Q4, driven by stronger demand in Europe and rising clinical adoption of its long‑read platforms. The company shipped multiple...
Gilead buys Genhouse cancer drug — $80M upfront
Gilead acquired global rights to an oral oncology candidate from China‑based Genhouse Bio in a deal that includes an $80 million upfront payment. Genhouse, which recently filed for an IPO in Hong...
BridgeBio’s oral dwarfism pill wins Phase 3 — regulatory filing planned
BridgeBio reported positive top-line results from Propel 3, its global Phase 3 study of oral infigratinib in children with achondroplasia. The trial met its primary endpoint, showing statistically...
FDA rejects Disc Medicine’s bitopertin — voucher fast-track fails
The FDA issued a rejection letter for Disc Medicine’s bitopertin, a candidate for a rare porphyria, citing uncertainties about the blood-based biomarker used as the trial’s efficacy endpoint. Disc...
Moderna’s flu program stalled: FDA refuse-to-file sparks industry alarm
Moderna received a refusal-to-file letter from the FDA for its mRNA influenza vaccine application, and company executives expressed surprise at the agency’s decision. Moderna said it had submitted...
NIAID told to deprioritize pandemic work: agency pivots under NIH directive
Internal emails obtained by Nature indicate that the National Institute of Allergy and Infectious Diseases has been instructed to remove references to "pandemic preparedness" and "biodefense" from...
FDA removes boxed warnings for six menopausal HRTs — label overhaul takes effect
The FDA finalized label changes removing the boxed warnings about cardiovascular disease, breast cancer and probable dementia from six menopausal hormone replacement therapies (HRTs). The agency...
Lyell launches first head‑to‑head CAR‑T trial — challengers to market incumbents
Cell therapy developer Lyell Immunopharma initiated a head‑to‑head CAR‑T trial that will compare its experimental product directly against marketed CAR‑T therapies. The trial structure is novel...
European investors form life‑sciences coalition — capital push for biotech
Leading venture firms and research institutions launched the European Life Science Coalition to mobilize private and public capital for the continent’s biotech sector. Members managing over €24...
NIH All of Us reaches 1M participants — dataset hits diversity target
The NIH announced that the All of Us Research Program achieved its goal of collecting genetic and health data from 1 million Americans representative of national diversity. The milestone provides...
Quantx closes $85M Series B — oral immunology drugs move toward clinic
Quantx Biosciences raised an $85 million Series B to advance two oral immunology candidates—an oral STAT6 inhibitor and an IL‑17 oral inhibitor—into clinical trials. The oversubscribed round will...
Ultragenyx cuts 10% of staff amid manufacturing and regulatory setbacks
Ultragenyx announced a workforce reduction of about 130 roles, roughly 10% of its headcount, as part of a restructuring aimed at reaching profitability in 2027. The move follows disappointing...
FDA refuse-to-file — Moderna’s mRNA flu program stumbles
The FDA issued a refuse‑to‑file for Moderna’s next‑generation mRNA influenza vaccine, halting the agency review the company expected and prompting scrutiny of trial design and comparator choice....
Rare‑disease approvals derail: Disc and PTC hit regulatory roadblocks
The FDA rejected Disc Medicine’s bitopertin for a rare porphyria disorder, citing uncertainties about the surrogate biomarker that underpinned the company’s efficacy claims. The decision came even...
BridgeBio’s win — infigratinib clears Phase III hurdle in achondroplasia
BridgeBio announced positive top‑line results from a global Phase III study of oral infigratinib in children with achondroplasia, meeting the trial’s primary endpoint for accelerated annualized...
Lyell launches head‑to‑head CAR‑T trial — experimental therapy to face marketed rivals
Cell therapy developer Lyell has initiated a first‑of‑its‑kind trial that tests its experimental CAR‑T product directly against marketed CAR‑T therapies. The head‑to‑head design aims to generate...