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Emulate partners with AstraZeneca to accelerate development of Organs-on-Chips technology

Emulate, Inc. has formed a collaborative partnership with AstraZeneca's Innovative Medicines and Early Development Biotech Unit to embed its Organs-on-Chips technology within the laboratories of the IMED Drug Safety organization.

16 May 2018

First epoetin alfa biosimilar receives FDA approval to treat certain types of anemia

The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

16 May 2018

FDA approves new drug to treat MS in pediatric patients

The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.

14 May 2018

FDA seeks order of permanent injunction to stop two stem cell clinics from marketing stem cell products

The U.S. Food and Drug Administration, in two complaints filed today in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.

10 May 2018

FDA grants approval for two drugs administered together to treat aggressive form of thyroid cancer

The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

8 May 2018

FDA authorizes marketing of Hemospray device for treating GI bleeding

Today, the U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

8 May 2018

Artificial retinas fabricated using organic printing inks may restore vision to blind people

A simple retinal prosthesis is being developed in collaboration between Tel Aviv University in Israel and Linköping University in Sweden. Fabricated using cheap and widely-available organic pigments used in printing inks and cosmetics, it consists of tiny pixels like a digital camera sensor on a nanometric scale. Researchers hope that it can restore sight to blind people.

2 May 2018

Kourtney Kardashian appears before Congress to voice her support of the Personal Care Products Safety Act

Kourtney Kardashian on Wednesday appeared before Congress to voice her support of the Personal Care Products Safety Act, a bill introduced by Sens. Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) that would require cosmetic companies to ensure that their products are safe before marketing them to consumers.

28 Apr 2018

BGS to promote high-quality sterilization services at Health GB in Manchester

BGS Beta-Gamma-Service, the German market leader for radiation sterilization, is set to expand its activities in the UK and will promote its services for the first time at Health GB Manchester from 30 April to 2 May.

18 Apr 2018

FDA authorizes marketing of first AI device to detect diabetic retinopathy

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.

12 Apr 2018

FDA grants clearance for first contact lens with light-adaptive technology

The U.S. Food and Drug Administration today cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light.

11 Apr 2018

German market leader for radiation sterilization set to expand in the UK

4 Apr 2018

FDA grants accelerated approval to leukemia drug for patients with MRD-positive ALL

The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).

30 Mar 2018

FDA permits marketing of Dexcom G6 integrated continuous glucose monitoring system

The U.S. Food and Drug Administration today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes.

28 Mar 2018

Researchers develop simple process for 3D bio-fabrication based on bacterial cellulose

Bacterial cellulose (BC) nanofibers are promising building blocks for the development of sustainable materials with the potential to outperform conventional synthetic materials.

26 Mar 2018

What gives the curl to curly hair? Sheep wool provides clues

There has been no research that explains what gives the curl to curly hair. To understand this, the researchers looked at the microscopic structure of the hair and measure the individual hair cells in the curly hair that could explain the curls. However human hair was found to be too thick for these experiments. So as a next step they looked at naturally curly hair or wool from six Merino sheep from New Zealand. This provided them with the answers they were looking for. The study results were published this week in the latest issue of the Journal of Experimental Biology.

23 Mar 2018

FDA expands approval of smaller size replacement heart valve for treating newborn pediatric patients

The U.S. Food and Drug Administration today expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.

7 Mar 2018

FDA approves new tests to detect tickborne parasite in human plasma and whole blood samples

The U.S. Food and Drug Administration today approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay, for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples.

7 Mar 2018

FDA approves new antiretroviral medication for patients with multidrug-resistant HIV

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).

6 Mar 2018

FDA reminds consumers to be wary of unapproved flu products

As part of the U.S. Food and Drug Administration's ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu.

5 Mar 2018