Latest Biotech News

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...

Tenax Therapeutics’ TNX-103 failed to hit the primary efficacy goal in a Phase 3 trial for heart failure associated with pulmonary hypertension (PH-HFpEF), triggering an early investor retreat. In...

Sionna Therapeutics’ Phase 2 cystic fibrosis program for SION-719 failed to improve outcomes when added to Vertex’s Trikafta, prompting Sionna to stop advancing the add-on approach. The company...

Silence Therapeutics reported Phase 2 success for divesiran, positioning the company to move the gene-silencing therapy toward Phase 3 in polycythemia vera (PV). Silence said the treatment met the...

Silence Therapeutics said divesiran stabilized red blood cell levels in a Phase 2 PV trial, a result the company believes could position it against major upcoming options. In the 48-patient study,...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820 million upfront, with additional milestone payments of up to $500 million tied to performance for its ultra-rare epilepsy drug....

Sobi will pay $75 million upfront to Innate Pharma for rights to market lacutamab, agreeing to a total deal value of $580 million ahead of a planned Phase 3 push. The transaction gives Sobi market...

CSPC Pharmaceutical Group announced FDA IND approval for SYS-6037, its mpox mRNA vaccine injection co-developed with the Institute of Microbiology of the Chinese Academy of Sciences. The clearance...

WuXi AppTec won a preliminary injunction in the 1260H case after a judge ruled that the U.S. Department of Defense’s designation of the company as a “Chinese military company” was likely arbitrary...

BioNTech’s former chief strategy officer Ryan Richardson’s team secured $25 million in seed funding for a virtual cancer surveillance startup. The company’s focus is aimed at using ongoing, remote...

Novo Nordisk and Amazon Web Services struck an AI drug discovery pact that includes AWS as Novo’s preferred cloud and AI partner and the creation of a London innovation hub for joint...