USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...
Deal terms include $1.1B upfront and up to $400M milestones, positioning Novartis to internalize an N‑myristoyltransferase inhibitor payload platform for next-generation ADC development. Myricx’s lead ...
FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...
BioPhorum, a global forum for biopharmaceutical industry collaboration, has formed a new working group aimed at accelerating innovation across small molecule manufacturing. 1 The Synthetic Molecule ...
FDA cleared Tregzi to improve chronic GVHD-free survival, representing a non-pharmacologic strategy to reduce chronic GVHD while supporting immune reconstitution after allogeneic transplantation.
Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...
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, ...
Cohort composition spans sterile small molecules, APIs, commercial cell-culture biologics, rare-disease drug substance, and CGT capacity across NY, NJ, IN, and NC manufacturing hubs. Eligibility ...
Priority review follows phase 3 placebo-controlled evidence across SatraGO-1/2, presented at ASOPRS 2025, demonstrating improvements in proptosis, inflammation, diplopia, and patient-reported outcomes ...
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