The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

The treatment becomes the only approved twice-yearly option for pre-exposure prophylaxis for HIV prevention in the European Union.

This video clips offers topline findings from our survey of nearly 90 bio/pharma professionals on the impacts of Trump-era tariffs and trade policy.

This comprehensive overview of contemporary formulation strategies covers the drug product lifecycle from end to end, illustrating best practices for various formulation types seen through a CRDMO’s lens while also covering problem solving, the role of digital tools, and geopolitical changes.

FDA cites Indiana drug plant for contamination, pest issues, and unresolved equipment failures, raising concerns over pharma manufacturing quality.

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, may impact the development of radiopharmaceuticals as cancer treatments, Pharmaceutical Technology® spoke with Michael Ritchie, chief commercial officer of Champions Oncology.

The recall was in response to particulate matter found in the container.

The US-EU pharma tariff cap has been finalized at 15%, impacting manufacturing, supply chain, and quality and promoting domestic production and resilience.

The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.

Pharmaceutical Technology® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council, about recent government actions regarding kratom and concentrated 7-hydroxymitragynine (7-OH) products.

FDA’s recommendation to control 7-OH products under the Controlled Substances Act should help prevent competition between legitimate pharmaceutical medicines and those companies looking to circumvent FDA regulations, says Michael White, Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and Chair of the Kratom Consumer Advisory Council.

The guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for cancer treatment during clinical development.

The company will highlight how its GMP services combine engineering, consulting, equipment qualification, and facility validation to better integrate its services during Farmaforum, which is being held in Madrid from Sept. 17–18, 2025.

Dave Miller, PhD, explains how early formulation planning, novel platforms, and tailored approaches secure long-term protection against generics.

Based on an analysis done by the European Medicines Agency on the feasibility of alternatives, the European Commission maintains use of titanium dioxide in drug products.

Dave Miller, PhD, explains how environmental audits, waste reduction, and supply chain security are reshaping priorities in pharmaceutical manufacturing.

Orphan status was granted based on Phase II data showing that treatment with rilzabrutinib reduced flares and improved markers while demonstrating consistent safety.

Drug development for rare diseases leverages genetic targeting and drives innovation and investment in pharmaceutical technology as well as precision medicine, according to Dan Williams, PhD, CEO, SynaptixBio.

Dave Miller, PhD, discusses how shifting drug manufacturing to domestic CDMOs can improve quality, reduce rework, and enhance long-term efficiency.

Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in July 2025.

Dave Miller, PhD, explains how a development-first approach, scientific depth, and regulatory trust build lasting partnerships in the CDMO space.

The company’s commitment to its North Chicago, Ill. plant is part of a previously announced $10 billion capital investment earmarked for the expansion of US innovation and manufacturing capacity.

The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

Dave Miller, PhD, discusses how tailored solutions, trust, and lifecycle planning are redefining partnerships in bio/pharmaceutical development.

The new targeted pipeline will advance Nxera’s oral GLP-1 agonists, novel GPCR targets, and structure-based drug design to address obesity and related health conditions.