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FDA compliance officers detailed 2026 guidance updates, online drug sale enforcement, and a first-of-its-kind AI-related warning letter at the PDA/FDA Joint Regulatory Conference.

Sanofi’s Jack Prior discusses how biopharmaceutical manufacturers can assess whether process data is ready for human and AI use, and the role of data quality, accessibility, governance, and AI in manufacturing.

Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.

Dualitas will screen over 300,000 bispecific combinations for Roche, backing a deal worth up to $1 billion in immunology research.

FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.

Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.

FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.

Inebilizumab (Uplizna) cut MG-ADL scores by 1.9 points versus placebo, supporting its approval in Japan for myasthenia gravis.

Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.

As data volumes explode, clinical data harmonization, hybrid cloud, and AI are reshaping biopharma IT into the industry's core growth engine.

Insilico's Longevity Vaccines use circular mRNA to arm T cells against aging's earliest culprit cells, starting with immune rejuvenation.

GSK's new trispecific TCE targets 2 tumor antigens plus T cells, aiming to improve on the tolerability of current myeloma therapies.

This episode of the BioPharm Brief highlights Roche’s Tam-Peli phase 3 survival data in relapsed small-cell lung cancer, Cellectis’ shift to in vivo gene editing for lipid disorders, and Phio Pharmaceuticals’ FDA briefing package for PH-762 in cutaneous squamous cell carcinoma.