Saturday, 13 June 2026

Vol. 1 · No. 11 Saturday, 13 June 2026 “The record does not wait for certainty; it waits for consequence.”

FDA & Regulatory

FDA Approves Capivasertib Plus Abiraterone for PTEN-Deficient mHSPC, Clears Roche's First IHC Companion Diagnostic for PTEN Protein Loss

The June 12 dual action — a full drug approval and the first FDA-approved companion diagnostic for PTEN protein loss in prostate cancer — creates an immediately actionable clinical workflow for roughly one in four men with metastatic hormone-sensitive prostate cancer.

Dr. Nadia Haq, Devices & Diagnostics Desk · 2 min read

The FDA on June 12, 2026 granted full approval to capivasertib (TRUQAP, AstraZeneca) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. On the same day, the agency approved Roche’s VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry companion diagnostic to detect PTEN protein loss in prostate adenocarcinoma, enabling clinicians to identify which patients are eligible for the new regimen.

The action is a full approval, not an accelerated pathway decision — a distinction that matters given the prior ODAC vote (7-1 in favor) and the trial’s enrollment scope.

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Also leading today

Public Health

CDC Ties 137 Cases to Moringa Supplement Outbreaks; One Rosabella-Brand Strain Carries NDM-1 Resistance Gene

Three linked but distinct investigations now cover 36 states and 39 hospitalizations. Health officials confirm the Rosabella cluster is the first documented NDM-1 Salmonella outbreak in the United States — but other strains in the moringa outbreaks remain treatable.

James Carter, Public Health Desk · 2 min

FDA & Regulatory

FDA Clears Dexcom Stelo as First OTC Continuous Glucose Monitor for Children as Young as Age 2

The June 12, 2026 510(k) clearance extends the Stelo biosensor's non-prescription indication to pediatric users who do not use insulin. The device does not alert for hypoglycemia and is not a substitute for a prescription CGM in insulin-dependent children.

Dr. Nadia Haq, Devices & Diagnostics Desk · 2 min

In brief

Research Sleep and Exercise Are Linked to Slower Clonal Blood Cell Expansion — But Only for Specific Mutations, Nature Study Finds A new Nature paper identifies mutation-dependent responses to lifestyle in clonal haematopoiesis: JAK2V617F and TET2-LOF mutations show sensitivity to sleep and exercise in mouse models, with associative signals in human cohorts. DNMT3A and TP53-LOF mutations did not respond.
FDA & Regulatory FDA Issues First-Ever Generic Animal Drug EUA — Nitenpyram Tablets for New World Screwworm Myiasis in Dogs and Cats Felix Pharmaceuticals' OTC nitenpyram tablets are now authorized for emergency use to treat — not prevent — confirmed or suspected screwworm infestations in dogs and cats weighing at least two pounds. Veterinary involvement is strongly recommended for wound management.
Clinical Trials Ecopipam Cuts Tourette Relapse Risk by Half in Phase 3 D1AMOND Withdrawal Trial The selective D1/D5 dopamine antagonist met its primary endpoint in the 216-patient D1AMOND study, with Emalex Biosciences now targeting an NDA filing — the first new mechanistic class for Tourette's in over five decades.
Opinion The Bundibugyo Lineage Is a Warning, Not Just a Diagnosis The genomic novelty of the 2026 Bundibugyo strain underscores a persistent gap in filovirus preparedness — one that the global health community has treated as a second-tier problem until now.

Trials Today

Phase 3 D1AMOND — Ecopipam for Tourette's Disorder — Randomized withdrawal trial (n=216, ages 6+) of ecopipam, a selective D1/D5 antagonist — mechanistically distinct from current antipsychotic tic treatments. Results published in JAMA Neurology; NDA pathway under discussion.
Phase 3 PRIOH-1 — Pritelivir vs. Foscarnet for Acyclovir-Resistant HSV — AiCuris trial (n=158) of oral helicase-primase inhibitor in immunocompromised patients with resistant mucocutaneous HSV completed per June registry update. Results not yet posted; first new HSV drug class to reach Phase 3 completion in decades.
Phase 2 Iberdomide Maintenance After Ide-cel CAR-T — NCI (SUSPENDED) — NCI suspended 74-site Phase 2 RCT (n=78 enrolled) of iberdomide CELMoD as maintenance after ide-cel in relapsed/refractory myeloma mid-study.

At the Agencies

FDA Approval — Capivasertib + Abiraterone (TRUQAP) for PTEN-deficient mHSPC — June 12 full approval based on CAPItello-281 Phase 3. First targeted therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer.
FDA CDx Approval — Roche VENTANA PTEN (SP218) RxDx Assay — June 12 FDA approval for first IHC companion diagnostic to identify PTEN protein loss in prostate cancer tissue. Paired with capivasertib approval.
FDA 510(k) — Dexcom Stelo OTC CGM for Ages 2+ — June 12 clearance using real-world evidence framework; no dedicated pediatric RCT required. First OTC CGM for pediatric use.
FDA CVM EUA — Generic Nitenpyram for New World Screwworm (Dogs & Cats) — June 11 EUA — first generic drug authorized under CVM emergency authority. Repurposes OTC flea treatment for screwworm myiasis as NWS outbreak spreads into Texas and New Mexico.

Who's Who

Susan Galbraith

Executive VP, Oncology R&D, AstraZeneca

Galbraith leads the AstraZeneca oncology unit that developed capivasertib; the AKT inhibitor received FDA full approval today for PTEN-deficient metastatic hormone-sensitive prostate cancer — paired with Roche's first IHC companion diagnostic for PTEN protein loss.

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