Our top 10 articles of 2025 covered pharma tariffs, MFN deals, FDA leadership changes, 483 quality issues, and a soar in MASH competition.

Mike Stenberg, LGM Pharma, outlines how GLP-1s, AI, and 505(b)(2) delivery shifts are driving pharmaceutical innovation.

Pharmaceutical Technology®’s quality experts, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel discuss how pharmaceutical manufacturing training has evolved over the years and how the influx of new facilities is demanding a skilled workforce.

In this look back at the year that was, in so many ways but in the bio/pharmaceutical industry especially, we remember 2025 as the point in time when AI declared it was here to stay.

Mike Stenberg, LGM Pharma, notes rising FDA audits in China/India and supply chain risks forcing deeper vetting and stock.

Frits Stulp, Implement Consulting, says AI and global collaboration are key to addressing patent cliffs and accelerating regulation.

André Cerbe, CEO of Schlafender Hase, spoke with Pharmaceutical Technology® about the disruptions the pharma industry faced in 2025 and how digital workflows will be key for success in 2026.

Frits Stulp, Implement Consulting, discusses the exciting potential of AI and “trusted regulatory spaces” for drug discovery and delivery.

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

FDA approve Cytokinetics’ Myqorzo for oHCM. The required REMS for heart failure risk aligns with key regulatory and safety foci.

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

With pharma sustainability regulations in most of the world getting stricter and partners requiring sustainable practices, it’s important for industry professionals to know the basics.

Dr. Eva-Maria Hempe, NVIDIA, looks back at 2025 and ahead to 2026, noting that AI accelerates pharma overall, particularly in manufacturing and business operations.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

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

Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.

In Episode 30, John Androsavich, Benjamin Fryer, and John Wilkerson go behind the headlines.

The FDA Commissioner’s National Priority Voucher pilot program has added J&J’s Tecvayli as the latest voucher recipient.

Life sciences is a decade behind other industries in its optimization and strategic exploitation of data. This is perplexing, given how much companies profess their ambitions to exploit AI. An industry podcast brought together life sciences thought leaders to debate the subject. The panelists noted that really, by now, standardized data should be yielding greater intelligence, and powering pharma’s future, accelerated by AI. If only companies could find new momentum to finally sort out their underlying data. This article sets out some of the key points that arose from the panel.

FDA leadership initiated rapid drug review programs, enhanced transparency by publishing decision letters in real time, and strategically integrated AI into agency operations.

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

Pharma R&D, formulation, and manufacturing are transforming via HPAPI advances, AI-driven automation, EU regulatory shifts, and patient-centric drug design.

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

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

A new facility in Tennessee will boost high-speed pharma packaging capacity and strengthen US supply chain support.

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.