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Drug Approval

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January 22, 2025
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Endocrinology Drug and Device Update

In a review of the 2024 milestones, Healio | Endocrine Today compiled a list of drugs and devices related to the field that were newly approved, cleared or had label or indication changes. Information was gathered from the FDA website and news releases. We put our best effort into making a complete list and regret any omission. Appearance of a drug or device does not constitute any endorsement by Healio | Endocrine Today, its editors, publishers or editorial board. — The Editors

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September 27, 2024
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FDA approves dupilumab for COPD with type 2 inflammation

The FDA has granted approval to dupilumab for treating adults with poorly controlled COPD with type 2 inflammation, according to a manufacturer-issued press release.

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July 05, 2024
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European Commission approves dupilumab for COPD with type 2 inflammation

The European Commission announced approval of dupilumab for treating adults with uncontrolled COPD with type 2 inflammation, according to a press release from Regeneron.

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July 02, 2024
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FDA approves injectable Kisunla for early symptomatic Alzheimer’s disease

The FDA approved Kisunla for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment and mild dementia with confirmed amyloid pathology.

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April 23, 2024
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‘Substantial uncertainty’ about clinical value of most accelerated approval cancer drugs

Less than half of the cancer therapies granted FDA accelerated approval showed meaningful improvement in survival or quality-of-life, study results presented at American Association for Cancer Research Annual Meeting showed.

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April 18, 2024
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VIDEO: AMD, geographic atrophy treatments advance with FDA approvals, recent innovations

In a video interview, Majda Hadziahmetovic, MD, retinal specialist and assistant professor of ophthalmology at Duke University discusses the FDA's approval of two new wet AMD treatments and the introduction of biosimilars into the field.

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April 02, 2024
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Top news of March: FDA PAH approvals, impacts of e-cigarette use

Healio has compiled the most-read news in pulmonology posted in March.

News
March 27, 2024
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FDA approves sotatercept for pulmonary arterial hypertension

The FDA has approved sotatercept, an activin signaling inhibitor, for treating adults with pulmonary arterial hypertension, according to a manufacturer-issued press release.

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January 31, 2024
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European Commission approves Hyqvia for chronic inflammatory demyelinating polyneuropathy

The European Commission has approved Hyqvia as maintenance therapy for individuals of all ages with chronic inflammatory demyelinating polyneuropathy.

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November 29, 2023
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Joint statement calls for FDA to require drug trials to include people with obesity

Five obesity advocacy organization have issued a joint statement asking the FDA to mandate that all drug approval trials include people with obesity.

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