Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...

Mass Photometry (MP) and Macro Mass Photometry (MMP) are complementary, label-free techniques that analyze biomolecules and therapeutic vectors directly in solution with single-particle resolution.

Pharma and biotech companies have access to an unprecedented variety of health data, from electronic health records and medical or pharmacy claims to genomic, behavioral and sensor data. Yet it can be ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...