October 29, 2026

FDA, CMS target gene therapy barriers

FDA and CMS initiatives aim to simplify gene therapy approvals and expand access to treatments for rare diseases.

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October 29, 2026

FDA proposes major infant formula update after nearly 30 years

Proposed changes target 4 key nutrients, requesting public input on whether additional ingredients should become mandatory.

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October 28, 2026

FDA adds generic valganciclovir oral solution

 The new option is indicated for CMV prophylaxis in pediatric kidney and heart transplant recipients, as well as adult CMV retinitis and transplant prophylaxis.

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October 26, 2026

FDA expands weekly insulin use to children

Insulin icodec-abae offers a weekly basal insulin option for pediatric type 2 diabetes, supported by adult trials and pediatric pharmacokinetic data.

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October 13, 2026

Alopecia therapy gains FDA breakthrough status

The designation covers an investigational botanical treatment for moderate-to-severe alopecia areata in patients aged 2 years and older.

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October 12, 2026

CDC: Measles cases surpass 4,000 in 2026

CDC data show that 96% of cases are outbreak-associated, with adults accounting for 40% of cases, up from 29% in 2025.

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September 29, 2026

First MCT8 deficiency therapy approved

Clinical studies showed reductions in circulating thyroid hormone levels and changes in heart rate and systolic blood pressure.

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September 28, 2026

FDA approves new treatment for FOP

Total new heterotopic ossification volume decreased with treatment and increased with placebo at week 24.

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September 28, 2026

FDA expands treatment in nephrotic syndrome

The indication marks an additional use for a therapy previously approved for certain cancers and active lupus nephritis.

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September 18, 2026

FDA approves gene therapy for MPS IIIA

The one-time intravenous treatment uses adeno-associated virus serotype 9 to deliver a functional copy of the SGSH gene.

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