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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

FDA clears first MRI device for neonatal brain and head imaging

Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging device specifically for neonatal brain and head imaging in neonatal intensive care units.

20 Jul 2017

Titanium dioxide nanoparticles can intensify inflammatory reaction in patients with colitis

Titanium dioxide, one of the most-produced nanoparticles worldwide, is being used increasingly in foodstuffs.

19 Jul 2017

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

Microscopic versions of the cocoons spun by silkworms have been manufactured by a team of researchers.

19 Jul 2017

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

The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.

18 Jul 2017

New report proposes strategy to evaluate low-dose toxicity of endocrine disruptors

A new report by the National Academies of Sciences, Engineering, and Medicine proposes a strategy that the U.S. Environmental Protection Agency should use to evaluate the evidence of adverse human health effects from low doses of exposure to chemicals that can disrupt the endocrine system.

18 Jul 2017

FDA approves first extended adjuvant therapy to lower risk of breast cancer recurrence

The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.

18 Jul 2017

Scientists develop new method to accurately determine functional age of cells

Sure, you know how old you are, but what about your cells? Are they the same age? Are they older, younger? Why does it matter?

11 Jul 2017

New treatment receives FDA approval to reduce complications of sickle cell disease

The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

7 Jul 2017

Re-engineered Multi-IR box accessory for the Integrity 10 Reaction Station launched by Electrothermal

Cole-Parmer Ltd, a leading UK manufacturer of laboratory equipment, announced today that Electrothermal has launched the re-engineered Multi-IR box accessory for the Integrity 10 Reaction Station. The Multi-IR box accessory, originally developed in conjunction with Pfizer and the Illinois Institute of Technology, enables scientists across a broad range of global industries and laboratories to measure turbidity in-situ during experiments.

From Cole Parmer Limited 5 Jul 2017

FDA expands use of cooling cap to minimize chemotherapy-induced hair loss in cancer patients

Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy.

3 Jul 2017

Cosmetics News and Research

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

New report proposes strategy to evaluate low-dose toxicity of endocrine disruptors

FDA approves first extended adjuvant therapy to lower risk of breast cancer recurrence

Scientists develop new method to accurately determine functional age of cells

New treatment receives FDA approval to reduce complications of sickle cell disease

Re-engineered Multi-IR box accessory for the Integrity 10 Reaction Station launched by Electrothermal

FDA expands use of cooling cap to minimize chemotherapy-induced hair loss in cancer patients

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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