Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

BMS is scaling AI drug discovery with new NVIDIA infrastructure, cutting research timelines via faster, more efficient computing power.

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market.

Brent Wilhelm, Cencora, talks on last-mile drug delivery risks, carrier network visibility, weather disruptions, and how AI could improve routing.

Checking in at 2026's midyear mark, LGM Pharma's Mike Stenberg revisits his 2025 predictions on inspections, onshoring, GLP-1 delivery, and AI adoption.

Megha Sinha, Kolter AI, discusses how digital twins run pharma supply chains but miss the regulatory execution needed to launch changes across markets.

Brent Wilhelm, Cencora, discusses why pharma supply chains still run on historical demand data and how AI could close the real-time visibility gap.

The future of compliant AI is not better content generation. It is better control over what happens next.

FDA finalizes bioequivalence guidance for topical corticosteroids and new meeting rules for OTC monograph drug sponsors, replacing a 1995 standard.

Manish Garg takes a midyear look back at his 2026 predictions: AI's shift from speed to strategy, supply chain resilience, and why NDC-12 is the next DSCSA moment.

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

Richard Jaenisch surveys pharma's biggest recent AI deals with Chris Cole in part one of a two-part breakdown of the major moves.

FDA proposes a hub-and-spoke manufacturing registration rule and approves three drugs for multiple myeloma, IgA nephropathy, and bladder cancer.

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

Epista's Henrik Johanning revisits his 2026 predictions on QRM, Annex 1, AI governance, and regulatory convergence: What's tracking, what isn't.

Force-displacement monitoring and LVDT verification may solve the cartridge press-fit challenge for greater than 99.5% yield.

CRB Group Fellow James Golden explains why solvent-driven hazardous-material infrastructure can become a major cost driver in oligonucleotide manufacturing facilities.

The future factory will be defined by how well automation tools work together with people, processes, and quality systems to make pharmaceutical manufacturing faster, smarter, more transparent, and more reliable.

Arcana Life Sciences' Remco Munnik revisits his 2026 predictions on EU regulatory reform, AI adoption, and data governance, and previews pharma's biggest challenges for H2 2026.

Dostarlimab monotherapy achieves sustained 12-month complete response in dMMR/MSI-H rectal cancer, potentially sparing chemo and surgery.

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments.

FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

Ocrelizumab biosimilar for multiple sclerosis: Teva and Polpharma Biologics sign global deal covering intravenous and subcutaneous forms.

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

It is essential to understand how raw material variability can create challenges in process control for autologous adoptive cell therapies.