Latest Biotech News

The FDA approved Moderna’s seasonal influenza mRNA vaccine mRNA-1010 (mFLUSIVA), marking the first approved flu shot built on an mRNA platform. The decision followed a unanimous VRBPAC vote,...

Bristol Myers Squibb selected Houston for a new $2.3 billion multi-modal manufacturing campus designed to support drug product and finished goods from late development through launch. The site...

Sionna Therapeutics said its cystic fibrosis strategy hit a wall in a Phase 2 trial, reporting that SION-719 did not provide additive benefit when combined with Vertex’s Trikafta. The company now...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences in a deal valued at just over $1.3 billion, consisting of $820 million upfront plus up to $500 million in milestone payments tied to...

Silence Therapeutics reported Phase 2 success for its siRNA therapy divesiran in polycythemia vera, hitting the trial’s primary endpoint in the 48-person study. Silence said 88% of patients...

A new gene-expression risk model is being used to personalize allogeneic stem cell transplant decisions for children with AML, aiming to refine who benefits most from allo-HSCT. The approach...

The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma. Labcorp said the approval enables patient selection for...

CMS’s Medicare GLP-1 Bridge program is reshaping weight management pricing by setting a flat $50 monthly copay point for eligible beneficiaries through December 31, 2027. The program runs outside...

Natera said it is expanding beyond its existing MRD footprint after a series of regulatory milestones for Signatera. The company received FDA approval for companion diagnostic use in...

China is tightening oversight of investigator-initiated trials (ITTs), a model that has helped accelerate trial starts but has increasingly drawn scrutiny. A STAT+ report said new enforcement is...

The FDA approved Moderna’s seasonal influenza mRNA vaccine (mRNA-1010, mFLUSIVA) for adults, marking the first FDA clearance for an mRNA flu shot in the U.S. The approval followed a unanimous...

Alamar Biosciences reported a sharp revenue rebound in its first full quarter as a public company, alongside an expansion of a large-scale plasma proteomics collaboration tied to Alzheimer’s. In...

Sionna Therapeutics ended its cystic fibrosis add-on strategy after a Phase 2 trial failed to show benefit when paired with Vertex’s Trikafta. In the Precision CF study, Sionna’s SION-719 plus...

Silence Therapeutics announced Phase 2 success for divesiran in polycythemia vera, setting up a move into Phase 3 for the gene-silencing therapy. In the 48-patient trial, Silence said 88% of...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences in a deal that could total more than $1.3 billion, adding a clinical-stage precision therapy targeting KCNT1-related epilepsy. Under the...

U.S. lawmakers are advancing a proposed trial-reform approach that would embed clinical research into routine care to speed up first-in-human study starts. The effort, linked to a “Hauchincloss”...

Qiagen received FDA clearance for a gram-positive bacterial and fungal bloodstream infection test that runs on the QiaStat-Dx platform, extending the company’s BCID assay menu in the U.S. The...

Labcorp said the FDA approved PGDx elio tissue complete as a companion diagnostic for BRAF V600E and V600K mutations in melanoma, expanding access to mutation testing that guides targeted...

FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical therapy candidate for neuroendocrine tumors after manufacturing problems surfaced during review. The decision delays a potential...

AbCellera reported Phase 2 results for a NK3R-targeting therapy in vasomotor symptoms, positioning its program to compete for share in the hot-flash treatment market. The company’s shares rose...