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FDA Leadership Shakeup: Vinay Prasad's Departure Sparks Industry Reactions
Vinay Prasad has abruptly left his role as head of the FDA's Center for Biologics Evaluation and Research following controversial regulatory decisions including halting Sarepta Therapeutics’...
Eli Lilly’s Mounjaro Shows Cardiovascular Safety in Major Diabetes Trial
Eli Lilly’s diabetes drug Mounjaro matched the cardiovascular safety profile of the company's older drug Trulicity in a large cardiovascular outcomes trial involving type 2 diabetes patients....
Respiratory Viral Infections Reactivate Dormant Breast Cancer Cells in Lungs
A multidisciplinary research team has uncovered direct evidence that common respiratory viruses—such as influenza and SARS-CoV-2—can reactivate dormant metastatic breast cancer cells in the lungs....
Madrigal Pharmaceuticals Secures $120M for Preclinical GLP-1 Agonist from CSPC
Madrigal Pharmaceuticals has entered an exclusive global licensing agreement with CSPC Pharmaceutical Group for SYH-2086, a preclinical oral small-molecule glucagon-like peptide-1 (GLP-1) receptor...
Saga Diagnostics Gains Medicare Coverage for Breast Cancer Recurrence Test
Saga Diagnostics’ Pathlight molecular residual disease (MRD) test has received positive Medicare coverage through the MolDx program for surveillance monitoring of breast cancer recurrence across...
Nautilus Biotechnology Focuses on Targeted Proteomics Amid Platform Development
Nautilus Biotechnology reported Q2 2025 financial results and highlighted progress in developing its proteome-scale single-molecule proteomics platform, targeting a 2026 launch. The company...
Novavax Reports Development of Vaccine Candidate Against Avian Influenza
Novavax has announced progress on a vaccine candidate targeting the avian influenza A(H5N1) virus, clade 2.3.4.4b. The vaccine aims to address pandemic threats arising from bird-to-human and...
Gene Therapy at Birth Shows Durable Protection Against HIV in Primates
A pioneering gene therapy study using adeno-associated virus (AAV) vectors demonstrated that a single injection of broadly neutralizing antibody (bNAb) genes delivered at birth can provide...
New AI System Automates Design and Analysis of CRISPR Gene Editing
Researchers from Stanford, Princeton, Google DeepMind, and UC Berkeley have developed CRISPR-GPT, an AI-driven agentic system that automates the design and analysis of CRISPR gene-editing...
FDA Leadership Shakeup Rocks Biotech Stocks
Vinay Prasad abruptly resigned as director of the FDA's Center for Biologics Evaluation and Research (CBER) amid controversy surrounding gene therapy approvals and policy disputes. His tenure saw...
Alnylam’s Amvuttra Sales Surge Post-Label Expansion
Alnylam Pharmaceuticals raised its 2025 revenue forecast after its drug Amvuttra, used for treating hereditary transthyretin amyloidosis, saw rapid sales growth following a label expansion....
Madrigal Secures CSPC’s GLP-1 Agonist with $2B Deal
Madrigal Pharmaceuticals inked an exclusive global licensing agreement worth over $2 billion to develop CSPC Pharmaceutical’s preclinical oral GLP-1 receptor agonist SYH-2086. The partnership aims...
Saga Diagnostics Scores Medicare Coverage for Breast Cancer MRD Test
Saga Diagnostics achieved a key milestone with Medicare coverage granted for its Pathlight molecular residual disease test, designed to monitor breast cancer recurrence across all subtypes. Backed...
Myriad Genetics Secures $200M Credit Facility from OrbiMed
Myriad Genetics closed a $200 million credit deal with OrbiMed to support its growth and operational objectives. The credit includes $125 million funded with an option for an additional $75...
Prima Mente Launches Alzheimer’s Epigenetic Clinical Study
Prima Mente is set to initiate a clinical trial deploying its Pleiades whole-epigenome platform to stratify Alzheimer’s patients for optimized management. Utilizing machine learning-enabled...
Respiratory Viral Infections Trigger Reactivation of Dormant Breast Cancer Cells
A pivotal study in Nature reveals that common respiratory viruses such as SARS-CoV-2 and influenza can awaken dormant metastatic breast cancer cells in the lung microenvironment. Experiments in...
Moderna Cuts Workforce by 10% Amid Cost Reduction Drive
Moderna announced layoffs affecting more than 500 employees, approximately 10% of its workforce, as part of a $1.5 billion cost-saving initiative through 2027. CEO Stéphane Bancel emphasized the...
Frazier Life Sciences Raises $1.3 Billion for Early-Stage Biotech
Venture firm Frazier Life Sciences closed an oversubscribed $1.3 billion fund targeting early-stage biopharmaceutical investments, surpassing the previous $987 million raised in 2022. This fund...
Eli Lilly’s Mounjaro Shows Cardiovascular Benefits in Large Trial
Eli Lilly’s diabetes medication Mounjaro demonstrated cardiovascular outcomes comparable to existing treatments in a large-scale trial. The drug reduced the risk of heart-related events by 8%...
FDA Leadership Shift and Sarepta Gene Therapy Controversy
Vinay Prasad's abrupt departure as Director of the FDA’s Center for Biologics Evaluation and Research (CBER) has sent shockwaves through the biotech sector. Prasad's tenure, though brief, was...