The U.S. Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from public health threats including the Coronavirus Disease
The US Food and Drug Administration approved a Duchenne muscular dystrophy drug yesterday (December 13) that it had originally rejected in August, reports STAT. The
A treatment regimen for extensively drug-resistant tuberculosis could help stem the growing problem of hard-to-treat TB infections in developing countries, according to the Associated Press.
The US Food and Drug Administration issued a safety alert for fecal transplant procedures after two immune-compromised patients contracted drug-resistant infections, according to a statement
The US Food and Drug Administration has approved esketamine to treat adults whose depression hasn’t responded to other antidepressants, the agency announced in a statement
An investigative report uncovers little recognized and unpoliced potential conflicts of interest among those who serve on FDA advisory panels that review drugs. Some members
The US Food and Drug Administration today (June 25) approved for the first time a marijuana-derived drug, Epidiolex, for the treatment of two rare forms
FDA approved Spark Therapeutics’ gene therapy Luxturna™ (voretigene neparvovec-rzyl) for treating children and adults with the rare inherited blindness disorder biallelic RPE65 mutation-associated retinal dystrophy.
Summary Nearly all of the roughly 64,000 Americans who died from opioid overdoses in 2016 succumbed because their breathing shut down, triggered by the effects
Following reports of patient deaths, the FDA has placed clinical holds on three trials assessing Merck & Co.’s approved cancer immunotherapy Keytruda® (pembrolilzumab) in combination
Cancer is increasingly being viewed as an ecosystem, a community in which tumor cells cooperate with other tumor cells and host cells in their microenvironment.
An advisory panel to the US Food and Drug Administration (FDA) convened Tuesday (November 24) to evaluate the strength of evidence for drisapersen, a drug
At first glance, SPRITAM looks like any other pill. But the drug, developed by pharmaceutical company Aprecia, is actually layers of powder laid down by
The US Food and Drug Administration (FDA) has approved the anti–PD-1 drug nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of metastatic squamous non–small-cell lung cancer
After years of debate, the US Food and Drug Administration (FDA) is poised to allow the sale of biosimilars, cheaper versions of complex and expensive
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