The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods.

The new targeted pipeline will advance Nxera’s oral GLP-1 agonists, novel GPCR targets, and structure-based drug design to ...

Dave Miller, PhD, discusses how tailored solutions, trust, and lifecycle planning are redefining partnerships in bio/pharmaceutical development.

Thermoplastic elastomers (TPE) offer a PFAS-free solution for stoppers in parenteral packaging, ensuring a safer and more ...

FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing ...

For the first target addressed in the partnership, the two companies reported the successful delivery of AI-designed, ...

The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora ...

Orforglipron showed clinically meaningful results at 72 weeks, after three doses, in a pool of more than 3000 adults.

Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, ...