Development

Surface modification with targeting ligands increases the advantages offered by nanoscale delivery.

Fondazione and Orphan Therapeutics outline a US access model for Waskyra, highlighting new approaches to manufacturing, distribution, and sustainability.

Charles River has launched a second cohort to speed CGT innovation with technical guidance and scalable manufacturing support.

The new GSK–Oxford BioTherapeutics partnership capitalizes on proteomics-driven oncology target discovery for advancing antibody therapeutics development.

FDA’s approval of the first Wiskott-Aldrich gene therapy signals a shift in manufacturing and regulatory standards for rare-disease CGTs.

FDA’s clearance of a chemically enhanced stem cell therapy for severe aplastic anemia drives forward cell therapy development and manufacturing innovation.

Priority review, RMAT, and breakthrough status were key regulatory actions intensely accelerating advanced next-gen therapy development in 2025.

Under the expanded agreement, the companies are targeting amyloid removal strategies to address unmet needs in rare diseases.

siRNA-based cell reprogramming shows potential to improve metabolic health with durable effects, signaling a notable development for future therapeutic strategies.

Engineered exosomes could reshape therapeutic development by redefining delivery, manufacturing models, and regulatory standards.

FDA outlines reduced primate testing for monoclonal antibodies, signaling a shift toward modern evaluation tools that may influence drug development practices.

The new collaboration will aim to streamline formulation-to-manufacturing workflows and de-risk development.

FDA’s internal findings raise new concerns over pediatric vaccine safety and signal potential regulatory shifts affecting future COVID-19 vaccine development.

How is the biopharma industry solving manufacturing and scale-up bottlenecks for cell and gene therapies? Read on to find out.

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.

Sapient said the workflow will allow for direct measurement of more than 10,000 protein groups in a single, 5-µm slide.

RxCelerate and Constructive Bio will combine programmable biology with integrated discovery tools to speed engineered biologics for hard-to-treat diseases.

Webinar Date/Time: Tue, Dec 9, 2025 11:00 AM EST

The new strategic collaboration seeks to develop up to four first-in-class myeloid cell engagers offering broad and safe treatment for blood and solid cancers.

Webinar Date/Time: Thu, Dec 11, 2025 11:00 AM EST

Biogen reports CHMP support for an enhanced nusinersen regimen, signaling potential shifts in SMA treatment strategies and global regulatory decisions.