Cover storyWhy Quality Culture Starts with Leadership explains how leaders, not SOPs alone, shape behaviour, ownership and fearless reporting in pharmaceutical quality.
Rigel's VEPPANU becomes the first FDA-approved PROTAC therapy, generating $6.6M in Q3 sales and raising novel CMC and QA challenges for the industry.
FDA grants Janssen accelerated approval for subcutaneous Rybrevant Faspro in platinum- and checkpoint inhibitor-refractory HNSCC under Project Orbis.
Cabaletta Bio targets a Q1 2028 BLA submission for rese-cel, citing standardized CAR-T manufacturing and weight-based dosing as core to its regulatory strategy.
Allogene's ALPHA3 Phase 2 trial expands into Asia-Pacific, raising GMP and supply chain demands for allogeneic CAR-T manufacturing at scale.
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