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Inhaling unfragmented hyaluronan improves lung function in COPD patients

Researchers at the National Institutes of Health and their collaborators found that inhaling unfragmented hyaluronan improves lung function in patients suffering from severe exacerbation of chronic obstructive pulmonary disease (COPD).

1 Feb 2021

FDA takes action on alcohol-based hand sanitizers from Mexico

As part of the U.S. Food and Drug Administration's continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products' safety.

26 Jan 2021

FDA approves first injectable, complete regimen for HIV-1 infection in adults

The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

21 Jan 2021

E-cigarettes stress and inflame the lungs, impair key regulatory proteins

E-cigarettes stress and inflame the lungs of rats, compromising important regulatory proteins through exposure, according to research recently published in the journal Redox Biology.

18 Jan 2021

FDA issues warning letters to firms selling e-liquids which lack premarket authorization

Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.

17 Jan 2021

CBP, FDA seize counterfeit, flavored e-cigarettes valued at over $719K

U.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have seized 33,681 units of e-cigarettes with a Manufacturer's Suggested Retail Price of $719,453.

13 Jan 2021

Study shows faster uptake of chemicals in people with a genetically weakened skin barrier

The ability of our skin to protect us from chemicals is something we inherit. Some people are less well-protected which could imply an increased risk of being afflicted by skin disease or cancer.

13 Jan 2021

FDA's AI/ML-Based Software as a Medical Device Action Plan released

Today, the U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.

12 Jan 2021

FDA conditionally approves first oral treatment for dogs with lymphoma

Today, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system.

11 Jan 2021

FDA alerts health care providers and clinical laboratory staff about SARS-CoV-2 viral mutation

The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test.

8 Jan 2021

FDA takes first steps in bringing clarity to emerging area of individualized drug development

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases.

4 Jan 2021

FDA approves first generic glucagon for injection to treat severe hypoglycemia

Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.

28 Dec 2020

FDA takes further steps to strengthen REMS program to confront opioid crisis

While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis.

23 Dec 2020

FDA authorizes first device to treat patients with walled-off pancreatic necrosis

Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal.

23 Dec 2020

FDA issues warning letters to companies illegally selling unapproved CBD products

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

22 Dec 2020

FDA issues first emergency use authorization for second COVID-19 vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

21 Dec 2020

FDA approves first adjuvant treatment for patients with non-small cell lung cancer

Today, the U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.

18 Dec 2020

FDA approves first implant system for adults who have above-the-knee amputations

The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have transfemoral—or above-the-knee—amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.

18 Dec 2020

FDA approves first oral drug for treating adult patients with advanced prostate cancer

Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.

18 Dec 2020

Certain male enhancement and weight loss products may pose serious health risk, warns FDA

The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk.

18 Dec 2020

Cosmetics News and Research

Inhaling unfragmented hyaluronan improves lung function in COPD patients

FDA takes action on alcohol-based hand sanitizers from Mexico

FDA approves first injectable, complete regimen for HIV-1 infection in adults

E-cigarettes stress and inflame the lungs, impair key regulatory proteins

FDA issues warning letters to firms selling e-liquids which lack premarket authorization

CBP, FDA seize counterfeit, flavored e-cigarettes valued at over $719K

Study shows faster uptake of chemicals in people with a genetically weakened skin barrier

FDA's AI/ML-Based Software as a Medical Device Action Plan released

FDA conditionally approves first oral treatment for dogs with lymphoma

FDA alerts health care providers and clinical laboratory staff about SARS-CoV-2 viral mutation

FDA takes first steps in bringing clarity to emerging area of individualized drug development

FDA approves first generic glucagon for injection to treat severe hypoglycemia

FDA takes further steps to strengthen REMS program to confront opioid crisis

FDA authorizes first device to treat patients with walled-off pancreatic necrosis

FDA issues warning letters to companies illegally selling unapproved CBD products

FDA issues first emergency use authorization for second COVID-19 vaccine

FDA approves first adjuvant treatment for patients with non-small cell lung cancer

FDA approves first implant system for adults who have above-the-knee amputations

FDA approves first oral drug for treating adult patients with advanced prostate cancer

Certain male enhancement and weight loss products may pose serious health risk, warns FDA

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