Latest Biotech News

The FDA has approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, expanding the PCSK9 class...

Sarepta has launched a new additional Phase III trial for Elevidys (Roche-licensed) after the European Medicines Agency denied marketing authorization in 2025 for failing to meet efficacy...

GSK has stopped development of camlipixant, its chronic cough drug acquired in a $2 billion Bellus Health deal, after Phase 3 results missed nearly all goals. The termination closes a blockbuster...

Dimerix has agreed to acquire Mission Therapeutics’ Phase 2-ready acute kidney injury asset, paying $5 million upfront and up to $287 million in milestones. The deal positions Dimerix to push the...

In a Phase I first-in-human study, researchers reported that a peptide vaccine targeting six common mutant KRAS variants (mKRAS-VAX) generated durable T-cell responses in high-risk pancreatic...

Braveheart Bio has disclosed its IPO path following licensing of Jiangsu Hengrui’s oral cardiac myosin inhibitor BHB-1893 for hypertrophic cardiomyopathy. The company reported encouraging Phase II...

AdvanCell has raised an oversubscribed $315 million Series D to fund development of its lead radiopharmaceutical candidate ADVC-001 and to expand isotope supply and manufacturing infrastructure....

Chai Discovery has raised $400 million in Series C financing, valuing the AI drug design startup at $3.8 billion. The company says its platform—used by large pharma partners such as Eli Lilly and...

Sanofi has filed lawsuits in the U.S. District of New Jersey alleging that Pfizer and Moderna violated its mRNA-related patents used in COVID-19 vaccine technology. The legal action adds to a...

Eli Lilly has agreed to acquire AtaiBeckley in a $2.8 billion upfront transaction, with potential additional milestone payments that could bring total deal value up to $3.8 billion. The...

The FDA cleared Merck’s Lipfendra (enlicitide), the first oral PCSK9 inhibitor, giving adults with hypercholesterolemia a new option to drive LDL-C lower than statins alone. The approval positions...

Eli Lilly agreed to acquire AtaiBeckley in a deal valued at $2.8 billion upfront, with potential additional milestone payments totaling up to $3.8 billion. The acquisition brings an intranasal...

Advancell raised an oversubscribed $315 million Series D to accelerate development of its L-212 prostate-specific membrane antigen-targeted radioligand, ADVC-001, and to expand isotope supply and...

A first-in-human phase 1 study of an mKRAS peptide vaccine (mKRAS-VAX) reported safe dosing and durable immune activity in high-risk pancreatic cancer cohorts. Investigators enrolled 20 people...

Washington University researchers described an in vivo “antibody–ADC click” approach designed to overcome antibody-drug conjugate resistance driven by heterogeneous or low target expression. Using...

Cincinnati Children’s Hospital reported preclinical evidence that an AAV-based gene therapy expressing human FMRP reverses multiple fragile X syndrome deficits in mice. Published in Gene Therapy,...

Qiagen expanded its infectious disease diagnostic footprint by receiving CE-IVD certification for its QiaStat-Dx BCID GN Plus AMR Panel, enabling gram-negative pathogen and antimicrobial...

A bipartisan U.S. Senate bill was reintroduced to increase vigilance around foreign companies manufacturing drugs in the U.S. pharmaceutical supply chain. The proposed “Pharmaceutical Investment...

Multiple teams reported AI-powered advances that directly expand therapeutic design toolkits. Researchers described synthetic, RNA-guided CRISPR-like nucleases designed using AI that rival or...

A new Nature Reviews Neurology review argues Lewy body disease may be driven by distinct “brain-first versus body-first” pathways, helping explain why symptoms fluctuate and why neurodegeneration...