The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...

In the latest installment of the PharmTech AI Pulse Check video series, Associate Editorial Director Christopher Cole is ...

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating ...

Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use ...

The FDA's expanding embrace of new approach methodologies (NAMs) is forcing pharmaceutical manufacturing and quality teams to rethink how preclinical and CMC data will be generated, validated, and ...

The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a ...

In June 1937, a salesman for the S. E. Massengill Company reported demand in the southern states for sulfanilamide in liquid ...

PharmTech covered one of the industry’s biggest events this week, as CPHI Milan was in full force with experts arguing that ...

The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral ...

Manufacturers are encouraged to treat resiliency policy as an actionable trend and proactively shape solutions rather than ...

Access Part 1 of this interview in which Scarboro explains why real-world usability belongs at product definition. Access ...

As publishers and research platforms such as Reaxys and Springer Nature build application programming interface (API) access ...