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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

Disinfectants could be helping bacteria to become resistant

News-Medical speaks to Professor Robert Bragg about disinfectants and how they could be helping bacteria to become resistant.

22 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

Domestic dogs unlikely to transmit SARS-CoV-2, say researchers

Researchers in Spain and Germany have conducted a study showing that domestic dogs are unlikely to contribute to the transmission and community spread of SARS-CoV-2 – the agent that causes COVID-19.

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

Changes to gut microbiome help melanoma patients respond to immunotherapy

Statistical modeling developed by Oregon State University researchers has confirmed that changes to melanoma patients' gut microbiome led them to respond to a type of treatment capable of providing long-term benefit.

16 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

Portable suitcase lab for rapid detection of SARS-CoV-2

The PCR test is the most accurate tool to identify SARS-CoV-2. However, valid results are often available only after days.

12 Feb 2021

BioRescue research project exemplifies challenges posed by global pandemic

The BioRescue research project, a program aiming at saving the northern white rhinoceros from extinction, exemplifies the challenges to overcome when conducting research and conservation in an international consortium in times of a global pandemic.

10 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

Novel dural puncture-sealing device decreases cerebrospinal fluid leakage

These leaks could be the cause of strong headaches that can last weeks, delaying recovery following an intervention with this anesthetic technique or making it more difficult for the mother to care for her child following childbirth with an epidural.

6 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

Study indicates that 2019-2020 flu season was driven by a new, more transmissible strain

The 2019-2020 flu season in the U.S. was unusual in a number of ways. Cases picked up in August rather than the more typical fall and early winter months, and it hit children particularly hard. It was also dominated early on by a Type B influenza virus instead of one of the much more common Type A viruses like H1N1 or H3N2.

5 Feb 2021

Experimental vaccine diminishes fatal respiratory effects of synthetic opioids

As the opioid epidemic raged on with an even greater force during COVID-19, the Scripps Research laboratory of chemist Kim Janda, PhD, has been working on new therapeutic interventions that may be able to prevent the bulk of deaths from opioid overdose.

4 Feb 2021

CoCID project aims to develop soft X-ray microscope for visualizing cellular origin of diseases

CoCID (Compact Cell Imaging Device), a €5.7 million, four-year, pan-European research and innovation project, funded through Horizon 2020, has officially commenced.

2 Feb 2021

Ebola survivors experienced a resurgence in antibody levels after recovery

A high proportion of survivors of Ebola experienced a resurgence in antibody levels nearly a year after recovery, a new University of Liverpool study has found.

27 Jan 2021

Veterinary News and Research

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

Disinfectants could be helping bacteria to become resistant

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

Domestic dogs unlikely to transmit SARS-CoV-2, say researchers

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

Changes to gut microbiome help melanoma patients respond to immunotherapy

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

Portable suitcase lab for rapid detection of SARS-CoV-2

BioRescue research project exemplifies challenges posed by global pandemic

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

Novel dural puncture-sealing device decreases cerebrospinal fluid leakage

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

Study indicates that 2019-2020 flu season was driven by a new, more transmissible strain

Experimental vaccine diminishes fatal respiratory effects of synthetic opioids

CoCID project aims to develop soft X-ray microscope for visualizing cellular origin of diseases

Ebola survivors experienced a resurgence in antibody levels after recovery

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How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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