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First duodenoscope with disposable distal cap approved by FDA

The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing.

20 Sep 2017

Study finds unsafe lead levels in red cosmetic powder used during Hindu ceremonies

Sindoor -- a cosmetic powder sold in the United States and used during Hindu religious and cultural ceremonies -- has unsafe levels of lead, according to a Rutgers University study.

19 Sep 2017

FDA grants accelerated approval to new drug for treating relapsed follicular lymphoma

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

14 Sep 2017

FDA grants approval for new biosimilar to treat multiple types of cancer

The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

14 Sep 2017

CFDA's NIFDC and IIVS re-affirm, expand partnership to bring non-animal test methods to China

Bo Li, Director General Director of the CFDA's National Institute for Food and Drug Control and Erin Hill, President of US based non-profit, Institute for In Vitro Sciences, Inc., signed a Memorandum of Understanding to bring non-animal test methods to China for the regulation of cosmetics and ingredients.

7 Sep 2017

FDA approves drug to treat patients with newly diagnosed CD33-positive AML

The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).

1 Sep 2017

FDA grants clearance for first 2D digital mammography system with patient-assisted compression

Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

1 Sep 2017

FDA approves first cell-based gene therapy for use in the United States

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

30 Aug 2017

FDA approves new antibacterial treatment for adults with cUTI

The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

30 Aug 2017

FDA grants accelerated approval to new treatment for children with Chagas disease

The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

29 Aug 2017

FDA issues warning letter to US Stem Cell Clinic for significant deviations

The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

28 Aug 2017

Study reveals possible medical and industrial properties of avocado seed husks

A new study presented at the 254th National Meeting & Exposition of the American Chemical Society (ACS), suggests that avocado seed husks contain a treasure of unidentified chemical compounds which has the potential to be used in treating various debilitating diseases such as, cancer and heart diseases, as well as in enhancing perfumes, cosmetics and other consumer goods.

22 Aug 2017

FDA provides panel of human plasma samples to evaluate serological tests for detecting Zika infection

As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.

18 Aug 2017

$FDA approval provides new, targeted treatment option for adults with relapsed or refractory B-cell ALL$

FDA approval provides new, targeted treatment option for adults with relapsed or refractory B-cell ALL

The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

17 Aug 2017

FDA warns against use of many drugs, dietary supplements due to potential contamination

The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.

11 Aug 2017

FDA approves new treatment for all HCV genotypes 1-6

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.

3 Aug 2017

Cosmetics News and Research

First duodenoscope with disposable distal cap approved by FDA

Study finds unsafe lead levels in red cosmetic powder used during Hindu ceremonies

FDA grants accelerated approval to new drug for treating relapsed follicular lymphoma

FDA grants approval for new biosimilar to treat multiple types of cancer

CFDA's NIFDC and IIVS re-affirm, expand partnership to bring non-animal test methods to China

FDA approves drug to treat patients with newly diagnosed CD33-positive AML

FDA grants clearance for first 2D digital mammography system with patient-assisted compression

FDA approves first cell-based gene therapy for use in the United States

FDA approves new antibacterial treatment for adults with cUTI

FDA grants accelerated approval to new treatment for children with Chagas disease

FDA issues warning letter to US Stem Cell Clinic for significant deviations

Study reveals possible medical and industrial properties of avocado seed husks

FDA provides panel of human plasma samples to evaluate serological tests for detecting Zika infection

FDA approval provides new, targeted treatment option for adults with relapsed or refractory B-cell ALL

FDA warns against use of many drugs, dietary supplements due to potential contamination

FDA approves new treatment for all HCV genotypes 1-6

FDA clears first MRI device for neonatal brain and head imaging

Titanium dioxide nanoparticles can intensify inflammatory reaction in patients with colitis

Researchers produce 'silk micrococoons' that could store sensitive molecular materials

FDA approves fixed-dose combination tablet for treating adults with chronic hepatitis C

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