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The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.

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.

At a critical turning point in the adoption of digital tools across the bio/pharma industry, we want to hear to industry professionals on where things actually stand.

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

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.