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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

Research predicts which mammal species can spread SARS-CoV-2

Scientists worldwide are fighting to contain the ongoing COVID-19 pandemic, which has already claimed more than 2.48 million lives. Preventing spillback infections is essential to containing the pandemic. To do so, it is vital to understand the nature of the virus, i.e., its susceptibility to a range of hosts.

23 Feb 2021

FDA issues guidance for medical product developers to address the emergence of SARS-CoV-2 variants

Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.

22 Feb 2021

Some nutritional supplements may help prevent or mitigate COVID-19 severity

A new study in the Journal of dietary supplements shows that nutritional supplements, including several vitamins and the mineral zinc, may be useful in preventing the infection or reducing its severity if caught.

22 Feb 2021

New single-payer bill intensifies Newsom’s political peril

A group of Democratic state lawmakers introduced legislation Friday to create a single-payer health care system to cover all Californians, immediately defining the biggest health policy debate of the year and putting enormous political pressure on Gov. Gavin Newsom.

19 Feb 2021

FDA warns 10 companies for selling unlawful dietary supplements that claim to treat mental health problems

Today, the U.S. Food and Drug Administration announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

19 Feb 2021

Uninherited genetic mutations can cause spina bifida

Genetic mutations which occur naturally during the earliest stages of an embryo's development can cause the severe birth defect spina bifida, finds a new experimental study in mice led by UCL scientists.

19 Feb 2021

USDA, FDA highlight no credible evidence of COVID-19 transmission through food or food packaging

After more than a year since the coronavirus disease 2019 (COVID-19) outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention continue to underscore that there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19.

18 Feb 2021

FDA approves novel 3D-printed talus implant for humanitarian use

Today, the U.S. Food and Drug Administration approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use.

17 Feb 2021

FDA approves drug to reduce frequency of chemotherapy-induced bone marrow suppression

Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer.

13 Feb 2021

Study investigates influence of adequate supply of vitamin D on prognosis of numerous diseases

In recent years, three meta-analyses of clinical studies have come to the conclusion that vitamin D supplementation was associated with a reduction in the mortality rate from cancer of around 13 percent.

11 Feb 2021

Partial replacement of animal proteins with plant proteins increases bone formation in adults

In a study conducted at the University of Helsinki, Finland, 136 adults adhered to one of three study diets for 12 weeks. One of them corresponded to the average Finnish diet, containing roughly 70% animal-derived protein of total protein, while most of the plant-based protein originated from cereal products.

11 Feb 2021

FDA issues EUA for bamlanivimab and etesevimab for COVID-19 treatment

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.

10 Feb 2021

FDA permits marketing of new prescription only device to reduce snoring and mild sleep apnea

Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea.

5 Feb 2021

$FDA approves cell-based gene therapy to treat adults with relapsed or refractory large-B-cell lymphoma$

FDA approves cell-based gene therapy to treat adults with relapsed or refractory large-B-cell lymphoma

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

5 Feb 2021

FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.

5 Feb 2021

FDA continues to support the development of medical products to tackle new virus variants

As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.

5 Feb 2021

Supplements News and Research

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

Research predicts which mammal species can spread SARS-CoV-2

FDA issues guidance for medical product developers to address the emergence of SARS-CoV-2 variants

Some nutritional supplements may help prevent or mitigate COVID-19 severity

New single-payer bill intensifies Newsom’s political peril

FDA warns 10 companies for selling unlawful dietary supplements that claim to treat mental health problems

Uninherited genetic mutations can cause spina bifida

USDA, FDA highlight no credible evidence of COVID-19 transmission through food or food packaging

FDA approves novel 3D-printed talus implant for humanitarian use

FDA approves drug to reduce frequency of chemotherapy-induced bone marrow suppression

Study investigates influence of adequate supply of vitamin D on prognosis of numerous diseases

Partial replacement of animal proteins with plant proteins increases bone formation in adults

FDA issues EUA for bamlanivimab and etesevimab for COVID-19 treatment

FDA permits marketing of new prescription only device to reduce snoring and mild sleep apnea

FDA approves cell-based gene therapy to treat adults with relapsed or refractory large-B-cell lymphoma

FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

FDA continues to support the development of medical products to tackle new virus variants

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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