Over the past four decades, rare disease drug development has evolved from a scientific aspiration into a central pillar of biopharmaceutical innovation. Regulatory reforms, scientific breakthroughs, ...

ACG’s Shirwal site is the first pharmaceutical packaging site in the WEF Lighthouse Network, using digital tools to cut ...

Discover proven strategies and innovative technologies to streamline microbial development, from early studies to GMP readiness. Learn from industry experts how to boost productivity, overcome ...

Cellares is partnering with Stanford Medicine to automate gene-edited stem cell therapy for HIV and more than 19 rare diseases.

Nine recommendations for extending therapeutic indications reflect ongoing lifecycle management and utility expansion of ...

Priority Review was granted by FDA for the first line metastatic TNBC treatment. Datroway significantly improved survival ...

In this forward-looking whitepaper, Blue Mountain explores how agentic AI —autonomous, context-aware AI agents—could ...

Dr. Stacy Lindborg is president and CEO of IMUNON, a clinical-stage company in phase 3 development with a lead DNA-mediated immunotherapy for advanced ovarian cancer. Dr. Lindborg has worked in the ...

The companies’ “Change the Target. Change What’s Possible” targets the potential of Factor XIa inhibition in the development ...

Currently, USP standards are utilized in 22,000 manufacturing facilities across 140 countries. Because of this massive scale, even small updates to these standards—such as those coordinated with the ...

EMA recommends Kygevvi for rare thymidine kinase 2 deficiency. It is the first authorized treatment for this disease.

EMA recommends Rezurock (belumosudil) for chronic graft-versus-host disease, with the drug. Meetings unmet needs via ...