Latest Biotech News

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...

The FDA approved Moderna’s mRNA-based seasonal influenza vaccine, mRNA-1010 (mFLUSIVA), marking the first approval for an mRNA flu shot in the US. The decision followed a unanimous vote by the...

Labcorp said the FDA approved its PGDx elio tissue complete as a companion diagnostic to identify BRAF V600E and V600K mutations in melanoma. The tissue-based next-generation sequencing assay...

Jazz Pharmaceuticals agreed to buy Actio Biosciences in a deal valued at just over $1.3 billion, including $820 million upfront and up to $500 million more tied to regulatory and sales milestones....

Sionna Therapeutics scrapped its cystic fibrosis add-on strategy after a Phase 2 failure of SION-719 when combined with Vertex’s Trikafta. The biotech said it will stop pursuing the program and...

AbCellera reported positive Phase 2 results for its NK3R-targeting program in a trial for vasomotor symptoms, or hot flashes. The company said the dataset beat Wall Street expectations, driving a...

Silence Therapeutics said its siRNA therapy divesiran succeeded in a Phase 2 study for polycythemia vera (PV) by meeting its primary endpoint. The company plans to advance the program into Phase...

AstraZeneca’s elecoglipron (ECC5004/AZD5004), an oral GLP-1 receptor agonist licensed from Eccogene, generated positive Phase 2 results in both obesity and type 2 diabetes. The company said the...

FDA rejected ITM Isotope Technologies Munich SE’s radiopharmaceutical therapy ITM-11 due to manufacturing issues, cutting off a potential competitor to Novartis’ radiopharma franchise. Separately,...

Broken String Biosciences launched BaseMap ABE, a genome-wide off-target characterization platform for adenine base editing therapeutics. The company said its INDUCE-seq-based approach generates...

STAT+ reported that China is tightening clinical-trial oversight, even as the US seeks ways to match China’s speed in bringing studies forward. The article focuses on how investigator-initiated...