September 11th 2025
Optimizing FDA 483 responses with strategic CAPA creates resilient quality compliance in biopharma manufacturing.
September 4th 2025
Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence
August 28th 2025The 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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
August 27th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
Celltrion Gains Expanded Indication Approval from FDA for its Actemra Biosimilar for CRS Therapy
August 9th 2025The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.
FDA Accepts Breyanzi sBLA from Bristol Myers Squibb and Grants It Priority Review for MZL
August 6th 2025Bristol Myers Squibb is seeking approval of Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory marginal zone lymphoma, making this the fifth cancer type for which the cell therapy would be approved.