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FDA grants approval for new device to treat breathing difficulty caused by severe emphysema

The U.S. Food and Drug Administration today approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema.

29 Jun 2018

FDA approves new marijuana-based drug to treat rare and severe forms of epilepsy

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.

25 Jun 2018

FDA grants marketing authorization for use of two catheter-based devices in hemodialysis patients

Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis.

22 Jun 2018

FDA expands approval of novel diabetes management device to include younger pediatric patients

The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes.

21 Jun 2018

FDA approves Eversense CGM system for use in adults with diabetes

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes.

21 Jun 2018

Study finds possible link between Type 2 diabetes and common white pigment

In a pilot study by a team of researchers at The University of Texas at Austin, crystalline particles of titanium dioxide -- the most common white pigment in everyday products ranging from paint to candies -- were found in pancreas specimens with Type 2 diabetes, suggesting that exposure to the white pigment is associated with the disease.

20 Jun 2018

Deep-frozen juices defrosted to room temperature can increase carotenoids level in body

Researchers from the Laboratory of Food Color and Quality at the University of Seville have published a study in which it is shown how certain types of cold treatment that are used by the citrus fruits industry in the preparation of juices have a great impact on the color of orange juice and on the concentration and bioaccessibility of the carotenoids present in the juice.

11 Jun 2018

European Union's criteria for regulating EDCs do not go far enough to protect public health

The Endocrine Society expressed continued concerns today that the European Union's (EU's) criteria for regulating endocrine-disrupting chemicals (EDCs) in pesticides and biocides do not go far enough to protect public health.

8 Jun 2018

FDA files complaint against company marketing unapproved hand sanitizers

The U.S. Food and Drug Administration today filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company's president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus, and Ebola.

7 Jun 2018

FDA warns nine online networks to stop illegal marketing of unapproved opioids

The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

6 Jun 2018

FDA warns companies to cease selling illegal, highly concentrated caffeine products

The U.S. Food and Drug Administration has issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products. The FDA considers these products to be a threat to public health.

6 Jun 2018

Genopole opens application process for Shaker and Booster programs to international candidates

Genopole, a French biocluster dedicated to research in the fields of genetics and biotechnology, today announces that it is now accepting applications for the third intake of its support programs titled Shaker, designed for people running innovative projects, and Booster, aimed at companies that are less than two years old.

5 Jun 2018

FDA approves first Neulasta biosimilar to help decrease infection risk during cancer treatment

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

4 Jun 2018

FDA approves first stand-alone prosthetic iris in the U.S.

The U.S. Food and Drug Administration today approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.

30 May 2018

FDA approves first oral medication for adults with moderately to severely active ulcerative colitis

The U.S. Food and Drug Administration today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis. Xeljanz is the first oral medication approved for chronic use in this indication.

30 May 2018

$FDA authorizes marketing of OsteoDetect software for detecting wrist fractures$

FDA authorizes marketing of OsteoDetect software for detecting wrist fractures

Today, the U.S. Food and Drug Administration permitted marketing of Imagen OsteoDetect, a type of computer-aided detection and diagnosis software designed to detect wrist fractures in adult patients.

25 May 2018

FDA approves novel enzyme therapy for adults with rare and serious genetic disease

The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).

25 May 2018

FDA approves new drug to treat thrombocytopenia in adults with chronic liver disease

The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.

22 May 2018

When is insurance not really insurance? When you need pricey dental care.

I'm 61 years old and a San Francisco homeowner with an academic position at the University of California-Berkeley, which provides me with comprehensive health insurance. Yet, to afford the more than $50,000 in out-of-pocket expenses required for the restorative dental work I've needed in the past 20 years, I've had to rely on handouts — from my mom.

21 May 2018

Reducing exposure to hormone interfering chemicals may mitigate obesity risk

Everyday products carry environmental chemicals that may be making us fat by interfering with our hormones, according to research presented in Barcelona at the European Society of Endocrinology annual meeting, ECE 2018.