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FDA nixes Disc Medicine’s porphyria drug — expedited voucher route fails
The FDA rejected Disc Medicine’s bitopertin application for porphyria, citing uncertainties about the link between the blood biomarker used in trials and clinical benefit. The agency’s decision...
BridgeBio’s oral FGFR3 drug clears Phase III — adds oral option for achondroplasia
BridgeBio reported positive top-line results from Propel 3: oral infigratinib improved annualized height velocity versus placebo in children with achondroplasia and achieved significant secondary...
FDA refuses to file Moderna’s flu vaccine — company and regulators at odds
The FDA issued a refuse-to-file for Moderna’s next‑generation mRNA influenza vaccine, surprising the company after months of dialogue. Moderna says it provided additional supporting analyses...
Vertex’s CRISPR drug rebounds — Casgevy sales more than triple
Vertex reported a strong commercial rebound for Casgevy, the CRISPR‑based gene editing therapy marketed with CRISPR Therapeutics, with sales more than tripling sequentially. Management framed the...
Exact Sciences posts Q4 beat — shareholders to vote on $23B Abbott deal
Exact Sciences reported fourth‑quarter revenue of $878.4 million, up 23% year‑over‑year and ahead of analyst estimates, driven by screening product momentum and growth in precision oncology...
All of Us hits 1 million participants — NIH achieves representative cohort
The NIH’s All of Us research program reached its long‑term enrollment goal of 1 million diverse participants, delivering the promised representative cohort for precision medicine research. NIH...
Lyell launches head‑to‑head CAR‑T trial — first test against marketed therapies
Lyell Immunopharma initiated a first‑of‑its‑kind clinical trial testing its experimental CAR‑T therapy directly against marketed counterparts, setting up a comparative study of efficacy and...
Quantx raises $85M — funds oral STAT6 and IL‑17 programs
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The financing will support IND‑enabling work...
Anterior grabs $40M — AI to speed care approvals for payers
Anterior secured $40 million to scale an AI platform that automates administrative clinical work for health plans, aiming to compress care‑approval timelines from weeks to minutes. MedCity News...
FDA trims boxed warnings on menopausal HRTs — risk statements narrowed
The FDA removed boxed warnings tying menopausal hormone replacement therapies to increased risks of cardiovascular disease, breast cancer and probable dementia for six HRT products. The agency...
FDA rejects Disc’s therapy: voucher fast-track falters
The FDA formally rejected Disc Medicine’s bitopertin for porphyria after questioning the link between the blood biomarker used in trials and clear clinical benefit. Disc, an early recipient of the...
BridgeBio’s oral drug clears Phase 3 — oral rival to Voxzogo
BridgeBio reported positive top‑line results from Propel 3: oral infigratinib achieved statistically significant gains in annualized height velocity in children with achondroplasia versus placebo....
FDA refuses to file Moderna’s flu vaccine — company blindsided
The FDA issued a refusal‑to‑file letter for Moderna’s next‑generation mRNA influenza vaccine, a move the company says came unexpectedly after years of engagement with regulators. Moderna...
Ultragenyx trims staff 10% as FDA stalls gene‑therapy plans
Ultragenyx announced a programmatic restructuring that will eliminate roughly 130 jobs—about 10% of its workforce—after a year of clinical setbacks and regulatory friction. Management tied the...
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...