FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.

Original title: “Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed”

Autoinjector offers at‑home dosing from start of treatment

Original title: “Leqembi Iqlik launches in US for early Alzheimer’s”

European ruling supports development in rare endocrine disorders

Original title: “Lundbeck gains EU orphan status for anti‑ACTH antibody”

Ziihera can now be used as an initial treatment for all HER2-positive gastroesophageal adenocarcinomas, dramatically expanding the drug’s market potential.

Original title: “New Jazz cancer drug approval could drive blockbuster sales”

The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.

Original title: “FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar”

While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.

Original title: “Bausch + Lomb advances dry eye disease drug to Phase 3 despite mid-stage fail”

First participant enrolled in EquilibriX S study

Original title: “VarmX begins global phase 3 trial for VMX C001”

Japan's early-access framework, South Korea's insurance coverage for enzyme replacement therapy, and China's expanded rare disease reimbursement policies are accelerating treatment availability. Growing clinical trial activity and healthcare infrastructure investment in India and Southeast ... Japan's early-access framework, South Korea's insurance coverage for enzyme replacement therapy, and China's expanded rare disease reimbursement policies are accelerating treatment availability. Growing clinical trial activity and healthcare infrastructure investment in India and Southeast Asia are expected to create additional opportunities through 2031. Expanded screening is identifying more Fabry patients, while gene, mRNA and oral therapies offer less burdensome, personalized care, with strong... Conversely, orphan-drug incentives, fast-track regulatory designations, and increased healthcare spending on rare diseases are expected to support future market expansion. Enzyme Replacement Therapy Maintains Market Leadership · Enzyme replacement therapy accounted for 67.85% of Fabry disease treatment market revenue in 2025. Its established safety profile and extensive clinical use continue to support its position as a primary treatment approach. North America generated 42.85% of global market revenue in 2025, supported by newborn screening, specialist treatment centers, established reimbursement systems, and active clinical trial recruitment. Regulatory pathways offering priority review and breakthrough designations are also encouraging faster adoption of innovative Fabry disease therapies across the United States and Canada.

Original title: “Fabry Disease Treatment Market 2026-2031 - Growth Driven by Increasing Adoption of Enzyme Replacement Therapy”

People who took "gray market" compounded retatrutide, an investigational triple hormone receptor agonist, achieved less weight loss with up to 12 months of treatment than clinical trial participants, a preprint study suggested. Epic data suggested the rate of hormone therapy use among outpatient women nearly doubled in recent years, rising from 1.7% in January 2017 to 3.6% in April 2026, with progestin-only and estrogen-only products driving most of the growth. Beyond aging, natural menopause was not linked to clinically meaningful changes in thyroid function, a Japanese cohort study found. (Journal of Clinical Endocrinology & Metabolism) Longitudinal data showed that earlier age of menopause was associated with faster cognitive decline, earlier Alzheimer's disease onset, and greater white matter hyperintensity accumulation. News and commentary from the endocrinology world

Original title: “'Gray Market' Retatrutide Study; Menopause and the Brain; Drug Allergy Warnings | MedPage Today”

The agency is now reviewing an updated application for deramiocel with a “refined” indication. Elsewhere, a startup co-founded by Vivek Ramaswamy is taking a speedy path to the public markets.

Original title: “FDA extends review of Capricor cell therapy; Pain drug startup to go public”

The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new target action date for the therapy is November 22.

Original title: “Capricor’s Duchenne therapy has new life after FDA grants 3-month extension”