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Covid shot in the arm not enough to keep pharmacies in business

Tobin's pharmacy and department store had already stocked its shelves with Easter and Mother's Day items last spring, and the staff had just placed the Christmas orders.

5 May 2021

FDA approves higher dose naloxone hydrochloride nasal spray product to combat opioid overdose

The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.

30 Apr 2021

New European research network addresses the effects of plastic particles on human health

Researching the effects of plastic particles on the human body and developing a health policy strategy for assessing the resulting risks is the goal of the new European research network PlasticsFatE. The University of Bayreuth, together with 26 other universities, institutes, and organizations from ten EU member states, is participating in the project.

29 Apr 2021

FDA issues noncompliance notice for failing to submit clinical trial summary results to ClinicalTrials.gov

Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise.

28 Apr 2021

Study characterizes anti-inflammatory effect of strawberry geranium on the skin

Strawberry geranium (Saxifraga stolonifera) has been used in Japan as a herbal medicine to treat wounds and swelling, and continues to be an ingredient in food and cosmetics.

23 Apr 2021

FDA authorizes marketing of a new device for use in patients undergoing stroke rehabilitation

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion.

23 Apr 2021

FDA approves immunotherapy for treating patients with dMMR endometrial cancer

Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.

22 Apr 2021

FDA approves immunotherapy for first-line treatment of advanced gastric cancer

Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

16 Apr 2021

FDA announces new action plan for reducing dietary exposures to toxic elements for children

Protecting one of our most vulnerable populations, babies and young children, is among the U.S. Food and Drug Administration's highest priorities.

8 Apr 2021

Chemical substances in some cosmetic and beauty products could increase risk of endometriosis

Researchers from the University of Granada and the "San Cecilio de Granada" Teaching Hospital confirm that endocrine disruptors—chemical substances that may mimic or block the action of hormones—are present in some cosmetic products

6 Apr 2021

FDA authorizes use of Symbiotica COVID-19 Self-Collected Antibody Test System

The U.S. Food and Drug Administration today announced it has issued an emergency use authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.

6 Apr 2021

FDA investigates contributing factors for reported infections from reprocessed urological endoscopes

Today, the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes—devices used to view and access the urinary tract.

1 Apr 2021

FDA takes action to advance OTC and other screening test development

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.

1 Apr 2021

FDA waiver broadens the use of chlamydia and gonorrhea test at more point-of-care settings

Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

30 Mar 2021

First cell-based gene therapy approved by the FDA for treating multiple myeloma

The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.

29 Mar 2021

Using molecular ‘cookie cutters’ to isolate first ever COVID-19 encounter complex

University of Birmingham researchers are working to isolate and extract the COVID-19 encounter complex in a form that is stable enough for identification of target sites for future anti-viral drugs.

27 Mar 2021

FDA authorizes marketing of new device for short-term treatment of gait deficit in MS patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS).

26 Mar 2021

FDA approves non-surgical heart valve to treat patients with certain types of congenital heart disease

Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs.

26 Mar 2021

FDA approves new indication for drug to treat pediatric NDO patients

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.

25 Mar 2021

FDA warns two companies for illegal marketing of unapproved CBD products

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

22 Mar 2021