Schmitt and Schniepp stress that merely citing a standard (e.g., "we followed GAMP") doesn't guarantee compliance. According ...

Accelerated approval relies on cornstarch-reduction as a surrogate endpoint, with crossover follow-up planned at 96 and 144 ...

The FDA approves first therapy shown to reduce new bone lesions and flare-ups in fibrodysplasia ossificans progressiva (FOP), ...

On August 19,2026, the FDA accepted Teva Pharmaceuticals' New Drug Application (NDA) for ecopipam, an investigational ...

Heidi Overton’s nomination could reshape FDA evidentiary expectations and policy signaling beyond vaccines, with downstream ...

A well-designed mixed FSP/FSO model is not a fixed operating structure, but an approach that evolves alongside a sponsor's portfolio. As programs mature, geographic footprints expand or resource ...

PPD, explains how mixed FSP/FSO models help sponsors balance speed, cost, and complexity in clinical trial outsourcing.

Post-marketing governance must be evidenced across the full lifecycle, design, validation, and live monitoring, not documented once and assumed to hold. For the past 2 years, the conversation about ...

The collaboration will use Andelyn’s viral vector process to produce clinical-grade material for an upcoming gene therapy trial. The disease category includes Tay-Sachs disease and Sandhoff disease, ...

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control ...

LEO Pharma acquires dersimelagon from Tanabe Pharma for up to $435M, adding a late-stage oral rare dermatology asset under FDA review. On August 18, 2026, LEO Pharma announced it has agreeded to ...

FDA approved florquinitau F 18 PET for AD evaluation in cognitively impaired adults, while excluding non-AD tauopathies because safety and effectiveness outside that population remain unestablished.