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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

Ubiquitous microplastics can become 'hubs' for antibiotic-resistant bacteria

It's estimated that an average-sized wastewater treatment plant serving roughly 400,000 residents will discharge up to 2,000,000 microplastic particles into the environment each day.

22 Mar 2021

FDA authorizes first machine learning-based COVID-19 non-diagnostic screening device

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).

20 Mar 2021

FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway

Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.

17 Mar 2021

Propylparaben exposure during pregnancy may lessen protection against breast cancer

Low doses of propylparaben - a chemical preservative found in food, drugs and cosmetics - can alter pregnancy-related changes in the breast in ways that may lessen the protection against breast cancer that pregnancy hormones normally convey, according to University of Massachusetts Amherst research.

16 Mar 2021

Organ-on-chip consortium receives huge grant to develop a universal standard for pharmaceutical industry

Scientists are pushing ahead building 'organ-on-chips', small chips with human cells, which are useful, for example, for studying cancerous metastases in the bloodstream or the development of scar tissue, or for testing the effect of drugs or food outside a human body.

10 Mar 2021

FDA authorizes first molecular non-prescription, at-home COVID-19 test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use.

5 Mar 2021

FDA issues emergency use authorization for T-Detect COVID Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization for the T-Detect COVID Test developed by Adaptive Biotechnologies.

5 Mar 2021

FDA plans to further reduce toxic elements in foods for babies and young children

The U.S. Food and Drug Administration takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population.

5 Mar 2021

FDA alerts consumers about improper use of thermal imaging systems, warns firms for marketing unapproved devices

The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and "fever cameras"—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors.

5 Mar 2021

Federal court order requires New York-based dietary supplement manufacturer to cease operations

A dietary supplement manufacturer and two of its executives have been ordered by a federal court to stop manufacturing, holding, or distributing any articles of food, including dietary supplements, until they come into compliance with federal dietary supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements.

4 Mar 2021

FDA clears new robotically-assisted surgical device for transvaginal hysterectomy

The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients.

1 Mar 2021

FDA grants emergency use authorization for QuickVue At-Home COVID-19 Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

1 Mar 2021

FDA to finalize the issuance of emergency use authorization for vaccine distribution

Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.

27 Feb 2021

FDA approves Nulibry to reduce risk of death caused by rare genetic, metabolic disorder

Today, the U.S. Food and Drug Administration approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A, a rare, genetic, metabolic disorder that typically presents in the first few days of life, causing intractable seizures, brain injury and death.

27 Feb 2021

FDA undertakes new action in its ongoing response effort to COVID-19 pandemic

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

27 Feb 2021

FDA permits marketing of new device to protect athletes from harmful effects of head impacts

Today, the U.S. Food and Drug Administration authorized marketing of a new device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts.

26 Feb 2021

FDA allows flexible storage and transportation conditions for Pfizer-Biontech COVID-19 vaccine

Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.

26 Feb 2021

FDA approval provides targeted treatment option for patients with rare DMD mutation

Today, the U.S. Food and Drug Administration granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping (Exons are pieces of DNA that provide information for making proteins in a person's genome).

25 Feb 2021

Cosmetics News and Research

FDA approves new indication for drug to treat pediatric NDO patients

FDA warns two companies for illegal marketing of unapproved CBD products

Ubiquitous microplastics can become 'hubs' for antibiotic-resistant bacteria

FDA authorizes first machine learning-based COVID-19 non-diagnostic screening device

FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway

Propylparaben exposure during pregnancy may lessen protection against breast cancer

Organ-on-chip consortium receives huge grant to develop a universal standard for pharmaceutical industry

FDA authorizes first molecular non-prescription, at-home COVID-19 test

FDA issues emergency use authorization for T-Detect COVID Test

FDA plans to further reduce toxic elements in foods for babies and young children

FDA alerts consumers about improper use of thermal imaging systems, warns firms for marketing unapproved devices

Federal court order requires New York-based dietary supplement manufacturer to cease operations

FDA clears new robotically-assisted surgical device for transvaginal hysterectomy

FDA grants emergency use authorization for QuickVue At-Home COVID-19 Test

FDA to finalize the issuance of emergency use authorization for vaccine distribution

FDA approves Nulibry to reduce risk of death caused by rare genetic, metabolic disorder

FDA undertakes new action in its ongoing response effort to COVID-19 pandemic

FDA permits marketing of new device to protect athletes from harmful effects of head impacts

FDA allows flexible storage and transportation conditions for Pfizer-Biontech COVID-19 vaccine

FDA approval provides targeted treatment option for patients with rare DMD mutation

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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

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