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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 discussion in this Drug Digest video focuses on optimizing biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

ADC oncology platforms, FDA CNPV rapid review, and significant investment into US biologics manufacturing capacity led this week’s news.

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.

David Dodd, GeoVax Labs, opines on why vaccine platform diversity is critical in the United States.

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

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

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

News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.

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

Five leaders from across the bio/pharma sector explore the opportunities and challenges posed by FDA’s CNPV pilot program.