USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...
A single-registration pathway would allow distributed networks to add, remove, or relocate units with less administrative complexity while maintaining centralized quality oversight and improved FDA ...
Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
In regulatory news in June 2026, the US FDA accepted the first in silico drug development tool as part of its ISTAND program, ...
Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry. This week, regulators, dealmakers, and manufacturers converged on the same ...
This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers. In this episode of Ask the Expert, Siegfried Schmitt, vice president, Technical, at Parexel, ...
Optimization-by-design and early process development decisions determine downstream material, energy, solvent, and water intensity, making sustainability primarily a chemistry and engineering choice ...
Phased assessment allows CHMP to evaluate CMC, nonclinical, and clinical data as they mature, rather than waiting for a complete centralized marketing authorization application. High-priority ...
FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...
Dual BAFF/APRIL blockade targets upstream B-cell maturation/plasma cell survival; lowers Gd-IgA1 and autoantibodies, reducing immune complex deposition and glomerular inflammation. ORIGIN 3 interim ...
Teva gains exclusive commercialization rights for IV and SC ocrelizumab biosimilar formulations across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey, pending approvals.
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