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We answer readers’ top questions on limit of blank, limit of detection, limit of quantitation, acceptance criteria, and equivalence testing in analytical method validation.

This episode of The BioPharm Brief explores how next-generation biologics are reshaping oncology and autoimmune disease, from a first-line antibody-drug conjugate filing and a novel ADC entering the clinic to a major investment in in vivo CAR-T technology.

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.

Kelun-Biotech's sac-TMT has gained NMPA acceptance for a new first-line indication application in advanced triple-negative breast cancer.

Collaboration between suppliers and developers, as well as viral vector manufacturing simplification, are becoming critical to CGT's commercial future, says Brandon Pence of FUJIFILM Biosciences.

Iksuda Therapeutics has received FDA clearance of its IND application for IKS04, a CA242-directed antibody-drug conjugate paired with a novel dosing approach designed to improve solid tumor penetration, enabling a Phase 1 trial in gastrointestinal cancers.

FDA has granted priority review to Johnson & Johnson's Rybrevant Faspro for head and neck cancer, backed by 42% ORR in the OrigAMI-4 trial.

Today's episode explores how FDA expedited pathways continue to shape advanced therapy development, from new RMAT designations for cell and gene therapies to an advisory committee review that underscores the agency's evolving expectations for clinical evidence.

Aprea Therapeutics CEO Dr Oren Gilad discusses ASCO 2026 data for WEE1 inhibitor APR-1051 and the company's precision oncology strategy while at BIO 2026.

Allogene's cema-cel has received FDA RMAT and fast track designations for first-line consolidation therapy in high-risk large B-cell lymphoma.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Ocugen's OCU410, a one-time AAV gene therapy for geographic atrophy secondary to dry age-related macular degeneration, based on Phase 2 data showing a statistically significant reduction in lesion growth.