Drug Development

Research into Cold Cancers Heating Up

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Development of Gamma-Delta T-Cell Therapies

Activation and expansion are essential for success in both autologous and allogeneic therapies.

QbD for Small-Molecule Continuous Process Development

Continuous manufacturing and a quality-by-design development approach are a natural fit.

Innovation and Market Exclusivity in the EU

December 23, 2025

How will plans to rework medicines legislation in the European Union impact drug development, innovation, and market exclusivity?

EMA Director Sees Legislation Revamp as Highlight of 2025

December 19, 2025

Executive Director Emer Cooke presents EMA’s achievements for the year.

Multi-Compendial Compliance for Pharmaceutical Excipients–Part 1: A Practical Application of Specification Equivalence

December 17, 2025

The authors detail a practical application of specification equivalence to excipients testing to achieve in-house harmonization.

FDA’s CNPV Pilot Gives First Approval to Antibiotic for Pneumonia and Sinusitis

December 12, 2025

The approval was granted to USAntibiotics, with FDA saying it addresses pronounced antibiotic shortages in the past two decades.

EMA Calls New EU Pharma Legislation Most Significant in Two Decades

December 12, 2025

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

European Parliament Revamps Pharmaceutical Policy Framework

December 11, 2025

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

Indivumed, URMC Launch Joint Venture for Patient-Centric Cancer R&D

December 11, 2025

The collaboration will initially focus on advanced stages of solid cancers such as colorectal, pancreatic, lung, and breast, but may expand to other cancer types in the future.

FAQ: Key Innovations in Drug Delivery and Formulation in 2025

December 09, 2025

New drug delivery systems prioritize convenience and customization, using advanced technologies like nano-engineering and non-invasive routes to improve patient outcomes.

Trends and Challenges Impacting Highly Potent API Development

December 08, 2025

Increasing demand, complexity, and potency are driving innovation and investment in HPAPIs.

How Innovation and Risk Management Are Reshaping Modern Drug Manufacturing

December 08, 2025

The articles in this issue reflect an industry in transition, committed to innovation while ensuring safe, reliable, and forward-looking pharmaceutical production.