FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.

Charles Gibbons of Lachman Consultants and Michael Grischeau of AbbVie stressed AI governance, data integrity, and human oversight as essential to applying digital tools across labs and supply chains.

Scientific discovery, technological evolution, and market demands are constantly reshaping the landscape.

Aaron Cowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs.

Bothe data integrity and quality of data are critical for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

The performance of ARS Pharmaceuticals’ Neffy marginally outpaced historical reports of epinephrine injection effectiveness.

More than 700 out of 1000 senior executives surveyed believe that next-gen supply chains should be among the top tech priorities for life sciences organizations.

The PDA Regulatory Conference convenes more than 30 FDA experts to discuss cGMP excellence, compliance trends, and regulatory outlook, offering crucial insights for pharma manufacturing professionals.

Aficamten beat metoprolol for oHCM, EMA/WHO hit 10 yrs, Oxford and EIT collaborated on AI vaccine, Offit's FDA exit stirred policy, and Pistoia set agentic AI rule.

The nonprofit is calling upon its community of experts in both artificial intelligence and machine learning to continue building support for responsible adoption of AI in the bio/pharmaceutical industry.

The partnership, which has received £118 million (US$158 million) in research funding, aims to establish a better understanding not only of how the body fights infection, but also how vaccines protect it.

Paul Offit removed from FDA vaccine panel as RFK Jr. reshapes US immunization policy, raising concerns for bio/pharma and regulation.

Digital solutions help pharmaceutical manufacturers navigate the complex supply chain.

This article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.

Pharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.

Aficamten is a small-molecule cardiac myosin inhibitor that was compared for the first time in the trial to the standard-of-care beta blocker.

EMA and WHO have collaborated for a decade, with WHO utilizing EMA’s scientific expertise to fulfill its mandate to improve access to safe and effective medicines.

AC-201 is being developed in a novel, oral formulation as a potent inhibitor that binds to the pseudo kinase domain, JH2, of TYK2/JAK1.

Unichem Pharmaceuticals has issued a voluntary recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after the incorrect label was placed on the wrong product.

Cereno's PAH drug got FDA Fast Track. Novo plant cited for contamination. Gilead's HIV PrEP approved in EU. Nelson Labs expanded testing.

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

This article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

Dan Williams, CEO of SynaptixBio discusses drivers of rare disease drug development, including FDA incentives, priority review vouchers, and a growing recognition of unmet needs.

Cereno reports that its lead program, CS1, demonstrated encouraging efficacy while meeting its primary endpoint of safety and tolerability in a Phase IIa trial.

The laboratory services provider is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility.