Articles

Pharma companies reveal capacity expansions and strategic pivots at DCAT Week 2026, signaling where supply chain investment is heading.

DCAT Week 2026: Key Pharma Manufacturing Announcements

The FDA approved higher-dose semaglutide (7.2 mg) in 54 days under its new priority voucher program, signaling faster reviews for drug developers.

New Wegovy Dose Approved Under FDA’s CNPV

FDA’s 2024-2025 guidances and policy signals, when read together, point to a digital-by-default oversight model built on structured data exchange, more routine remote engagement, and clearer expectations for lifecycle control of automated systems used in regulated decisions. This article translates those signals into practical steps for chemistry, manufacturing, and control, as well as quality management systems.

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

What FDA's NAM Guidance Means for Pharmaceutical Development

Associate Director, IT Applications
Hikma

A framework for 2026 that moves beyond manual AI onboarding toward "zero-lag" integration for pharmaceutical manufacturing.

The AI-Synchronized CMO: A 2026 Mandate for Collapsing Onboarding Timelines and Orchestrating Operational Excellence in a Geopolitical Minefield

Cheryl Barton is director of PharmaVision, 

European biotech companies are exploring new therapeutic targets on T-cells to overcome drug resistance and improve clinical outcomes in cancer.

European Biotechs Pushing the Frontiers in Immunotherapy 

Head of Radiopharmacology, Champion Oncology

Videos

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.

Why PDX Models Improve Radiopharmaceutical Biodistribution Studies

The FDA approves icotrokinra, the first targeted oral peptide blocking the IL-23 receptor, for moderate-to-severe plaque psoriasis with Phase III data across 2,500 patients.

FDA Approves First Oral Peptide for Plaque Psoriasis

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

Creating Sustainable Operational Excellence in Pharma Manufacturing

SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like Alzheimer's and Parkinson's.

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