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Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidance...
We recognize that there is a high level of interest regarding FDA?s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency?s thinking on these issues. Today, the FDA released two separate draft guidances that will eac...
Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Cente...
Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency?s three medical product centers.
FDA confirms elevated levels of belladonna in certain homeopathic teething products
The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessa...
FDA approves first drug for spinal muscular atrophy
The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.
FDA permits marketing of new tissue expander for women undergoing breast reconstr...
The U.S. Food and Drug Administration today allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander.
Federal judge approves consent decree with California dietary supplement distribu...
A California dietary supplement distributor has been ordered by a federal court to stop selling its products, which were found to contain unsafe ingredients including 1, 3-dimethylamylamine (DMAA).
FDA permits marketing of first newborn screening system for detection of four, ra...
FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders
FDA approves new psoriasis drug
The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.
Exhausted immune cells linked to irritable bowel syndrome
Adelaide researchers have for the first time discovered that a specific type of irritable bowel syndrome is associated with exhaustion of the immune system in patients.
New research links genetic defects in carbohydrate digestion to irritable bowel s...
Irritable bowel syndrome (IBS) affects a large portion of the general population.
Fifteen possible causes of abdominal pain
What is abdominal pain, what are the causes, and what are the symptoms? Are some causes more serious than others? When should medical attention be sought?
What causes stomach pain at night?
In this article, learn about the common causes of nighttime stomach pain, the ways to prevent and treat nighttime stomach pain, and when to see a doctor.
Mucus in Stool: What Does it Mean?
Find out about the many reasons why there might be mucus in your stool. This article looks at the causes and possible treatments for mucus in stool.
HIV and diarrhea: Causes, treatment, and remedies
What is the connection between diarrhea and HIV, when might it occur, and how long does it last? Are there any complications with HIV and diarrhea?
Probiotics may help to prevent and treat colon cancer
A new study looks at the effect of Lactobacillus reuteri, a probiotic, on colon cancer development. In mice, it reduced tumor growth and inflammation.
Trance to treat stomach ache: the efficacy of medical hypnosis
Therapeutic hypnosis is an effective and safe complementary technique in surgery and the treatment of irritable bowel syndrome.
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