FDA

High price may keep deflazacort drug out of several patients’ reach

High price may keep deflazacort drug out of several patients’ reach

A drug recently approved by the Food & Drug Administration (FDA) to treat a rare form of muscular dystrophy may be out of reach of many patients due to its hefty price.
Marathon Pharmaceuticals will sell the FDA-approved deflazacort drug under the brand name Emflaza for nearly $89,000 for a year’s worth of treatment. The figure represents 70 times higher price for the drug than what it costs outside the United States.

MDA welcomes FDA approval for muscular dystrophy drug

MDA welcomes FDA approval for muscular dystrophy drug

The Muscular Dystrophy Association (MDA) has welcomed the U.S. Food & Drug Administration’s decision to approve Marathon Pharmaceuticals’ deflazacort drug to treat the most common childhood form of muscular dystrophy.

The deflazacort drug, labeled for use by individuals 5 years or older with Duchenne muscular dystrophy (DMD), can be used regardless of genetic mutation. It is third drug in 6 months approved by the FDA for diseases included in MDA’s program.

FDA approves Pfizer drug Crisaborole for atopic dermatitis

FDA approves Pfizer drug Crisaborole for atopic dermatitis

The U.S. Food & Drug Administration (FDA) on Wednesday approved the topical drug crisaborole for the treatment of mild to moderate itchy skin condition eczema or atopic dermatitis in patients aged two years and older.

Atopic dermatitis is a chronic inflammatory skin disease that causes red, flaking and crusted bumps on the patient's skin that are often extremely itchy.

FDA seeks public opinion on what they think ‘healthy’ should mean on food label

FDA seeks public opinion on what they think ‘healthy’ should mean on food label

The Food and Drug Administration (FDA) wants to know from you what you think about ‘healthy’ when it is mentioned on a food label. The step is considered to be good advancement towards the plan to provide consumers with all the information so that they can make informed food choices.

FDA launches 2016 Naloxone App Competition with aim to combat opioid overdose through app

FDA launches 2016 Naloxone App Competition that aims to combat opioid overdose through app

The US Food and Drug Administration has announced a competition, titled ‘2016 Naloxone App Competition’, with an aim to combat opioid overdoses.

Under the competition that will run from Friday through October 7, computer programmers, public health advocates, clinical researchers, innovators and entrepreneurs have been asked to create an app that connects the one suffering from an opioid overdose to the closest supply of naloxone.

FDA indicates some of stem cell treatments need regulation

FDA indicates some of stem cell treatments need regulation

The US Food and Drug Administration (FDA) now believes that some of the stem cell treatments need to be regulated as drugs therefore, they would require advance approval. The matter has resulted into a serious debate among patients, politicians and physicians.

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