Dave Miller, PhD, discusses how shifting drug manufacturing to domestic CDMOs can improve quality, reduce rework, and enhance ...

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 ...

Dave Miller, PhD, explains how a development-first approach, scientific depth, and regulatory trust build lasting partnerships in the CDMO space.

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

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

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.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse ...

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 ...

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