September 14, 2026

FDA broadens APDS treatment options

An 8-patient study evaluated safety and pharmacokinetics in the younger pediatric population.

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September 14, 2026

FDA approves muscle-targeted SMA therapy

The therapy inhibits myostatin signaling and is used with survival motor neuron 2-targeted treatment.

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September 14, 2026

FDA approves FET-PET agent for glioma

The radioactive diagnostic drug is indicated in patients aged 1 month or older and is used in conjunction with other diagnostic evaluations.

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September 04, 2026

FDA approves first therapy for Alexander disease

The antisense oligonucleotide reduces production of the abnormal protein that accumulates in supportive cells in the brain.

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August 31, 2026

Do antihistamines help atopic dermatitis?

First-generation H1 antihistamines likely increase cognitive impairment, with cognitive effects differing among second-generation antihistamines.

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August 28, 2026

FDA approves XFG-adapted COVID-19 vaccine

The 2026 to 2027 formulation aligns with FDA guidance on the preferred composition for COVID-19 vaccines beginning this fall.

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August 28, 2026

FDA monthly preview: Key September decisions to watch

Several FDA decisions across multiple specialties are expected this month.

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August 26, 2026

FDA approves HIV treatment for newborns

Study and pharmacokinetic data supported the application.

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August 26, 2026

FDA authorizes continuous ketone monitor

Patients aged 2 years and older with diabetes are eligible to use the wearable.

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August 25, 2026

FDA approves first therapy for warm autoimmune hemolytic anemia

The phase 2/3 ENERGY trial evaluated durable hemoglobin response with nipocalimab vs placebo in adults with warm autoimmune hemolytic anemia.

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