Regulatory Affairs

FDA finalizes potency assurance guidance for cell and gene therapies

The final guidance replaces FDA's 2011 potency testing document with a risk-based strategy that builds potency into manufacturing, not just release testing.

Anam · Nov 03, 2026 · 9 min read

Digital Health

AI auscultation flags weak heart pumping before the echo, outscoring cardiologists

A stethoscope recording heart sounds and ECG, read by a neural network, detected an ejection fraction of 40% or less with an AUROC of 0.904 in external validation.

Anam · Nov 02, 2026 · 7 min read

Clinical Trials

Lutikizumab meets phase 3 goal in hidradenitis suppurativa, but the margin is narrow

AbbVie's dual IL-1α/IL-1β antibody beat placebo on HiSCR75 in the 1,400-patient INTREPID trial, with an 8-point gap that is smaller than phase 2 suggested.

Anam · Oct 30, 2026 · 8 min read

Biotechnology

Lipid nanoparticles build CAR NK cells inside the body, skipping manufacturing

MIT researchers report that targeted lipid nanoparticles reprogrammed up to 80 per cent of natural killer cells in mice, clearing tumours and autoreactive T cells without ex vivo cell manufacturing.

Anam · Oct 29, 2026 · 8 min read

Neuroscience

Solengepras cuts Parkinson's OFF time in phase 3 without targeting dopamine

A once-daily GPR6 inhibitor reduced daily OFF time by 0.61 hours versus placebo in the ARISE trial, a phase 3 win for a non-dopaminergic approach to Parkinson's.

Anam · Oct 28, 2026 · 9 min read

Drug Discovery

AI-Designed TEAD Inhibitor ISM6331 Reports First-in-Human Data in Mesothelioma

Insilico's generative-chemistry pan-TEAD inhibitor shrank tumours in a few heavily pretreated mesothelioma patients at ESMO 2026. Here is what the small, company-reported dataset does and does not show.

Anam · Oct 26, 2026 · 8 min read

Oncology

Personalized mRNA Neoantigen Therapy Cuts Melanoma Recurrence in Phase 3

In INTerpath-001, intismeran plus pembrolizumab lowered the risk of recurrence or death by 42% in resected melanoma, with the benefit emerging only after vaccination ended.

Anam · Oct 24, 2026 · 8 min read

Genomics & Genetics

Atlas of 10 Million Immune Cells Traces How Disease Variants Reach Genes

Paired chromatin and RNA profiling of blood cells from 1,108 Finnish donors links non-coding variants to specific genes and explains why constrained genes hide their eQTLs.

Anam · Oct 23, 2026 · 8 min read

Research & Development

Ono Licenses Biohaven's IgG Degraders: What the MoDE Platform Does

An $80 million upfront deal brings a new way of clearing autoantibodies to Asia. Here is how the liver-directed degraders work and what the early Graves' disease data do and do not show.

Anam · Oct 22, 2026 · 8 min read

Regulatory Affairs

FDA Expedited IND Pilot Tests Rolling Review for First-in-Human Trials

Applications close 30 October for an FDA pilot that reviews first-in-human IND sections as they are finished, with sponsors paired with outside research institutions.

Anam · Oct 22, 2026 · 9 min read

Medical Devices

FDA Approves Hydrogel Spacer to Curb Scarring After Uterine Adhesion Surgery

Juveena, a gel that sets inside the uterus and clears in two to three weeks, cut adhesion recurrence in a blinded trial. Key figures come from a subgroup and await publication.

Anam · Oct 21, 2026 · 8 min read

Digital Health

Conversational AI Takes Histories Before Real Primary Care Visits

In a Lancet feasibility study at Beth Israel Deaconess, Google's AMIE chatted with 98 urgent care patients before their visits without a single safety stop. It had no control arm and a physician watched every chat.

Anam · Oct 20, 2026 · 8 min read