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FDA & Government News

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July 02, 2026

FDA Expands Gene Therapy for Younger Patients

Exagamglogene autotemcel is now indicated for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.

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June 30, 2026

FDA Names PreCheck Participants

Seven companies will participate in a two-phase program that provides early FDA technical guidance during development of new US pharmaceutical manufacturing facilities.

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June 30, 2026

FDA Expands Pediatric Roflumilast Use

The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.

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June 30, 2026

FDA Issues CRL for Oxylanthanum Carbonate

The action relates to previously identified third-party manufacturing deficiencies rather than concerns about the clinical efficacy or safety data, according to the company.

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Daily News

Stay up to date with the latest clinical headlines and other information tailored to your specialty.

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June 29, 2026

FDA Approves Pediatric Risankizumab

Approval expands risankizumab use to pediatric plaque psoriasis and psoriatic arthritis and includes a new 55-mg prefilled syringe for weight-based dosing in patients weighing less than 40 kg.

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June 29, 2026

Where Are Adults Getting Sunburned?

Water-related activities were the most commonly reported setting for recent sunburn, while more than one-half of respondents reported sunscreen use at the time of their most recent sunburn.

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June 29, 2026

Parkinson Mortality Rate Was 72 per 100,000 in 2024

The age-adjusted Parkinson disease death rate among US adults aged 65 years and older was 72.0 deaths per 100,000 standard population in 2024, lower than the 2021 rate, according to a National Center for Health Statistics Data Brief.

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June 26, 2026

FDA Approves New First-Line TNBC Regimen

Phase 3 results showed longer progression-free survival with pembrolizumab plus sacituzumab govitecan-hziy than with pembrolizumab plus chemotherapy in previously untreated PD-L1-positive advanced triple-negative breast cancer.

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