Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...

AAVs play a key role in delivering gene therapies, and precise measurement of the empty/full capsid ratio—a critical quality ...

Two biotech innovators launched products that solve challenges in gene therapy scale-up and learn from omics data from ...

When tested in a mouse model of breast cancer, the doxorubicin-loaded nanoparticles caused fewer side effects than free ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

RNA-seq and spatial transcriptomics showed immune cell subsets that drive kidney and lung complications in systemic sclerosis ...

The ability to make patient-specific products quickly fits with the needs of smaller, resource-limited developers.

The facility will be built to meet SFDA, FDA, EMA, and BMBL requirements and will include a fully integrated digital manufacturing platform.

For some trees, wasted bark is a potential treasure-trove of biopharmaceuticals—from anti-inflammatories to cancer-fighting ...

Barcelona’s blood and tissue bank says it has developed a new system for the large-scale production of mesenchymal stromal ...

The AI unicorn's Perturb-seq atlas is publicly available and detects dose-dependent genetic effects to enhance predictive ...

Noetik will use its multimodal AI models to identify which patients will most likely benefit from Agenus’s lead ...