Quality Systems

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

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

The FDA will evaluate tildrakizumab-asmn for psoriatic arthritis. A 2026 decision is expected based on Phase III clinical trial data.

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities.

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

Developments across the sector highlight a period of rapid acceleration and structural modernization.

The author discusses analytical techniques for cleaning and disinfection, clean room operation, packaging component preparation, water-for-injection production, sterile product preparation, and aseptic filling, stoppering, and sealing.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval.

In part three of this four-part series regarding rare diseases, the authors examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation.

PharmTech spoke with women working in the pharmaceutical industry about the innovations they are seeing in bio/pharma and the role women play in the development of critical treatments for patients.

In part two of this four-part series regarding rare diseases, the author examines how economic and structural forces are driving an access gap.

PharmTech spoke with Elisabeth Gardiner, chief scientific officer at Tevard Biosciences, about how hands-on, early exposure to STEM fields can demystify complex concepts.

FDA has granted priority review to AstraZeneca's Datroway for the first-line treatment of metastatic TNBC treatment.

The PreCheck Pilot Program is designed to strengthen the US pharmaceutical supply chain by increasing regulatory predictability and streamlining the assessment of new domestic manufacturing sites.

The European Commission has approved GSK’s adjuvanted recombinant respiratory syncytial virus vaccine, Arexvy, for use in adults aged 18 years and older.

The United States Pharmacopeia is developing digital standards for digital-first workflows and regulatory confidence.

Ensuring quality, sterility, and regulatory compliance are essential when choosing analytical methods.

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

To combat growth and pricing pressures, companies are auditing their supply chains and API material providers.

China clears GSK’s Nucala (mepolizumab) for COPD, highlighting growing acceptance in the country for biomarker-driven therapies.

This paper provides a technical assessment of compendial tests commonly found in the European Pharmacopoeia, the United States Pharmacopeia–National Formulary, and the Japanese Pharmacopoeia, detailing differences between the methods and acceptance criteria, and the potential impact of these differences on multi-compendial compliance.

In this overview, PharmTech takes a look back at significant news in the development and approval of cancer treatment in 2025.