8legs: U.s. food and drug administration

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#1 out of 38.42%

health12h ago

The FDA approved Eli Lilly’s GLP-1 oral pill for sale in the United States, marking a major expansion of obesity treatment into an oral option.
The lowest dose is expected to cost about $149 a month for people paying out of pocket, with higher doses possibly around $349, shaping access and insurer coverage.
Medicare could begin covering the drug for some patients as soon as this summer, with copays as low as $50 a month under a policy framework.

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#2 out of 3

health20h ago

The FDA granted accelerated approval for Avlayah, a new enzyme replacement therapy for Hunter syndrome, aiming to slow cognitive decline.
Avlayah is the first FDA-approved Hunter syndrome treatment in two decades that penetrates the blood-brain barrier.
Early treatment may extend life and prevent cognitive decline if started before brain damage occurs.
The drug targets cognitive decline, addressing a key unmet need in Hunter syndrome.
Families like Kim Stephens and Roran Jaskulski hope for stability and improved quality of life for their children.
The current standard treatment helps physical symptoms but does not halt cognitive decline.
Denali says it is engaging with payers to ensure rapid access to Avlayah for families.
The drug’s approval reveals ongoing FDA debates over rare disease treatments amid patient advocacy pressure.
The therapy marks progress in addressing neurodegenerative aspects, a breakthrough for families and researchers.
The drug Avlayah is priced at a list price of $5,200 per 150-milligram vial, with Denali prioritizing access.

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#3 out of 3

health12h ago

Nypost.com and 3 more

The FDA fast-tracked review of orforglipron reflects a broader push to shorten weight-loss drug approvals and speed patient access.
Orforglipron showed meaningful metabolic benefits beyond weight loss, with improvements in waist circumference, blood pressure, triglycerides, and cholesterol.
Orforglipron’s oral option offers convenience and could start around $25 per month for insured patients, addressing some cost barriers.

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