During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus ...
The FDA has approved a high-dose regimen of Biogen’s nusinersen (SPINRAZA) for the treatment of spinal muscular atrophy. 1 ...
Excipient innovation is part of a broader eco-design strategy that integrates sustainability into every stage of product development. By reducing energy consumption, minimizing waste, and sourcing ...
The adoption of daratumumab represents a major achievement in the application of delivery technologies, specifically the ...
Michelle Dennis, QC Microbiology Application Specialist with MilliporeSigma and member of the PDA Week 2026 planning ...
Under Project Optimus, the FDA now expects oncology sponsors to evaluate multiple clinically relevant doses using the totality of the evidence and to identify the dosage that “m ...
Ryan Murray, ValSource, breaks down far UVC technology, holistic contamination control strategies, and environmental ...
In this insightful interview, Richard Jaenisch, senior director of Education, Outreach, and Digital Experience at Open ...
Regulatory pressure from GxP, 21 CFR Part 11, and AI/ML guidance elevates requirements for audit trails, data lineage, ...
Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about ...
By incorporating these advanced models into preclinical packages for the FDA, researchers can provide a much stronger proof ...
Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP). Sat down with ...
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