May 2026– date –

Unified life-course model integrating UPF, gut microbiome, microplastics, PFAS, and metabolic dysregulation. Includes F. nucleatum stem-cell reprogramming and the latest 2026 reviews.

ACS 2026 statistics: colorectal cancer is now the #1 cancer death cause for U.S. adults under 50. Ten+ cancer types are rising in younger cohorts; 1960s-onward birth cohorts show systematic risk.

AI in pharmacovigilance — FDA/PMDA initiatives, social media and EHR-based signal detection, the future of drug safety.

Nature Medicine, May 2026: a structured 960-response test of ChatGPT Health's triage. 48% of emergencies undertriaged. Anchoring bias OR 11.7. Crisis safeguards activate counterintuitively.

On May 15, 2026, the FDA approved atezolizumab (Tecentriq, Genentech/Roche) for adjuvant treatment of muscle-invasive bladder cancer in patients with molecular residual disease (MRD), marking a landmark biomarker-guided approval in urothelial carcinoma.

On May 13, 2025, the FDA approved zenocutuzumab-zbco (Bizengri, Merus N.V.) for advanced or metastatic cholangiocarcinoma harboring NRG1 fusions, introducing a first-in-class NRG1-blocking bispecific antibody to clinical practice.

On May 15, 2026, the FDA approved Enhertu (T-DXd, Daiichi Sankyo/AstraZeneca) for two new indications in HER2+ early breast cancer (neoadjuvant + adjuvant for residual disease). pCR ~65-70%, iDFS HR 0.55. A reshaping of the early breast cancer paradigm.

On May 13, 2026, the FDA approved oral Inqovi (decitabine + cedazuridine, Taiho Oncology) plus venetoclax for newly diagnosed AML in adults ≥75y or unfit for IC. The first fully-oral, non-intensive AML regimen.

On May 13, 2026, the FDA granted accelerated approval to Beqalzi (sonrotoclax, BeOne) for R/R MCL post-BTKi. ORR ~70%, CR ~50%. The first BCL-2i monotherapy approval in MCL.

On May 1, 2026, the FDA approved VEPPANU (vepdegestrant) for ESR1-mutated ER+/HER2- advanced breast cancer. The first-ever PROTAC approval. VERITAC-2: PFS HR 0.57.

On April 2, 2026, the FDA granted traditional approval to Tecartus (brexu-cel, Kite/Gilead) for relapsed/refractory mantle cell lymphoma. ZUMA-2 Cohort 3 (BTKi-naïve): ORR 91%, CR 79%.

Virtual trials and in silico cohorts at Pfizer, Sanofi and beyond — will digital twins truly transform clinical trials?

Mechanistic modeling × AI for preclinical-to-clinical translation: PBPK, QSP, and digital twin frontiers.

How AI and robotics are transforming compound management — the quiet revolution that actually moves pharma P/L.

AI drug discovery company map (Insilico, Recursion, Isomorphic Labs, Schrodinger) and the real profit structure transformation behind the headlines.

Nuclear medicine next decade: shift from β (177Lu) to α (225Ac, 212Pb). α has 100× cytotoxicity, short range protects normal tissue. Pipelines: 225Ac-PSMA, 225Ac-FAP, 225Ac-DOTATATE (RYZ101), 212Pb-DOTAMTATE. New targets (FAP, GD2, HER2, αvβ6). Manufacturing wall (Oak Ridge, Karlsruhe, PSI, JAEA). Final volume.

Comparison of nuclear medicine competitors (Lantheus, Bayer, Telix, Lilly × Mariana, BMS × RayzeBio, AZ × Fusion) across 5 axes: diagnostic vs treatment, target molecules, isotopes, manufacturing infrastructure, partnerships. Emerging specialists (Aktis, Convergent, Perspective, Curasight, Clarity) and industry reshuffling scenarios. Vol. 2.

Novartis Pluvicto (mCRPC, $1B+ annual revenue) and Lutathera (NET) clinical and commercial success moved nuclear medicine from niche to mainstream. Short isotope half-life and specialized facility requirements make Vertical Integration (production-synthesis-distribution-delivery chain) decisive competitive advantage. Endocyte acquisition $2.1B, Point Biopharma $1.4B, 14-site global manufacturing network. Vol. 1.

The April 2026 issue of Nature Medicine published a landmark paper validating the real-world clinical utility of tumor whole-genome sequencing (WGS) in solid cancers. WGS identifies additional actionable findings in 10-20% of patients beyond standard panels — driving treatment changes, response, and survival. "WGS for the right patient, not every patient" — a tiered model is the realistic answer.

Structural comparison of CAR-T's three commercialization paths (autologous, allogeneic, in vivo) across 7 axes. Market projection: $16.5B in 2030, $35B in 2035, with in vivo's late-decade growth. Final volume.