Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in ...

The company’s commitment to its North Chicago, Ill. plant is part of a previously announced $10 billion capital investment ...

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

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

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

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

The company presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical ...

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

Experts from LGM Pharma and Rockwell Automation share their thoughts on what makes tech transfer effective, where processes ...

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

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

The program has been transitioned to a permanent pathway that is designed to support innovative tools like artificial ...