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Ultragenyx Pharmaceutical Inc.'s Crysvita (burosumab-twza) has been approved by the U.S. Food and Drug Administration to treat adults and children ages 1 year and older with x-linked hypophosphatemia.

FDA Approves First Drug for Rare Form of Rickets

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Crysvita approved for adults and children ages 1 year and older with x-linked hypophosphatemia
Artificial intelligence software that can detect diabetic retinopathy has been approved by the U.S. Food and Drug Administration.

FDA Approves AI Device to Detect Diabetic Retinopathy

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FDA permits marketing of novel artificial intelligence technology that can be used in primary care office
The U.S. Food and Drug Administration announced Friday that it has issued tough new restrictions on the sale of dietary supplements that contain dangerously high amounts of caffeine.

FDA Cracks Down on Caffeine-Loaded Dietary Supplements

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Products have been linked to at least two deaths in otherwise healthy people
The U.S. Food and Drug Administration has approved the first contact lenses that automatically darken in bright light

FDA Approves First Auto-Darken Contact Lenses

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Acuvue Oasys contact lenses with light-adaptive technology are soft contact lenses made for daily use
To help curb complications tied to the permanent contraceptive implant Essure

FDA Puts New Restrictions on Contraceptive Implant Essure

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Patients and physicians must sign acknowledgment of risks, benefits of implantation
The National Comprehensive Cancer Network often makes recommendations for new molecular entities beyond the indications approved by the U.S. Food and Drug Administration

NCCN Recommends New Drugs Beyond FDA-Approved Indications

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NCCN recommended 47 FDA-approved drugs for 113 indications; 39 percent were extra recommendations
The U.S. Food and Drug Administration has approved the world's smallest mechanical heart valve

FDA Approves Mechanical Heart Valve for Newborns

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Masters Series Mechanical Heart Valve now available in smallest size yet
The first set of blood screening tests for the tickborne parasite Babesia microti have been approved by the U.S. Food and Drug Administration.

FDA Approves First Screening Tests for Tickborne Parasite

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Babesia microti screening tests will help reduce risk of transfusion-transmitted infection
Trogarzo (ibalizumab-uiyk) has been approved by the U.S. Food and Drug Administration to treat adult patients living with HIV who have not responded to other antiretroviral medications.

FDA Approves New Medication for Drug-Resistant HIV

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Trogarzo is given intravenously once every 14 days in combination with other antiretrovirals
A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer

FDA Cracks Down on Kratom Products

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Missouri-based Divinity Products Distribution will recall and destroy kratom-containing products