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September 28, 2017 Avita Medical announced submission of U.S. FDA Premarket Approval (PMA) Application for the ReCell device for treatment of burn injuries. The PMA submission includes clinical data from the two U.S. randomized, controlled trials with combined enrollment of 131 patients at twelve leading burn centers across the United States.
Some are FDA-approved for weight loss, and others are prescribed off-label. Though they work differently, most weight loss prescription meds work by mimicking the hormones responsible for ...
Xywav is a medication used to treat cataplexy or excessive daytime sleepiness. [2] [3] It contains a mixture of the oxybate salts calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. [2]
Silver sulfadiazine, sold under the brand Silvadene among others, is a topical antibiotic used in partial thickness and full thickness burns to prevent infection. [1] ...
The FDA has approved one such injection, a drug called Kybella, from Kythera Biopharmaceuticals. However, the FDA on Wednesday noted the presence of unapproved fat-dissolving injections popping up ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
On Monday, GSK Plc (NYSE:GSK) shares were down after the Delaware State Court ruled that more than 70,000 lawsuits could proceed over its discontinued heartburn drug, Zantac (ranitidine). The ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
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