Latest Biotech News

The FDA approved Moderna’s seasonal mRNA flu vaccine, mRNA-1010 (mFLUSIVA), marking the first mRNA flu shot cleared in the U.S. for adults aged 50–64. The decision followed a unanimous VRBPAC...

CMS launched details of the Medicare GLP-1 Bridge program, creating a flat $50 monthly copay signal for eligible Medicare Part D beneficiaries seeking certain weight management drugs through a...

Cystic fibrosis challenger Sionna Therapeutics disclosed that its Phase 2 add-on strategy failed to improve sweat chloride versus Vertex’s Trikafta alone, sending shares down sharply and removing...

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

The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma, enabling patient selection for FDA-approved targeted...

Broken String Biosciences launched BaseMap ABE, a platform for genome-wide off-target characterization supporting adenine base editing therapeutic development. The company says BaseMap ABE...

Natera said it is expanding Signatera’s footprint in minimal residual disease testing and preparing to enter early cancer detection after multiple recent regulatory wins. In the last four months,...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences in a deal worth up to $1.3 billion, including $820 million upfront and up to $500 million in contingent payments tied to milestones. The...

Digital Science launched two Model Context Protocol (MCP) servers for its Dimensions research platform, aimed at giving enterprise AI agents direct access to a connected database of scientific and...

The FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical candidate ITM-11 for neuroendocrine tumors due to manufacturing problems, according to the company. The decision delays a...

The FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical candidate for neuroendocrine tumors, citing manufacturing problems and delaying a potential challenger to Novartis’...

Sionna Therapeutics said its cystic fibrosis drug SION-719 failed to deliver benefit when added to Vertex’s Trikafta in a Phase 2 trial. The study did not show a statistically significant...

The FDA approved Moderna’s mRNA-1010 (mFLUSIVA), marking the first FDA-authorized mRNA-based seasonal influenza vaccine. The decision came after a VRBPAC vote that determined benefits outweighed...

Jazz Pharmaceuticals agreed to buy Actio Biosciences in a potentially $1.3 billion transaction, adding a clinical-stage KCNT1 epilepsy program to its pipeline. Under the deal terms, Actio receives...

The FDA approved Labcorp’s PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma. The tissue-based assay is designed to help clinicians...

Sobi agreed to a $580 million deal involving Innate Pharma’s lacutamab program, securing rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer. The arrangement includes $75...

Broken String Biosciences launched BaseMap ABE, a genome-wide method built on its INDUCE-seq technology to characterize off-target effects in adenine base editing therapeutic development. The...

Bristol Myers Squibb disclosed plans for a $2.3 billion manufacturing campus in Houston, a sizable expansion tied to its broader investments in the United States. The new site is intended to...

University of Chicago Medicine Comprehensive Cancer Center and Eli Lilly launched a two-year partnership aimed at expanding patient access to cancer clinical trials. The effort is designed to go...

The U.S. Centers for Medicare & Medicaid Services moved forward with a new proposed device coverage pathway, laying out the Regulatory Alignment for Predictable and Immediate Device (RAPID) track...