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Scientists receive the Brain Prize for groundbreaking contributions to novel migraine therapies

The Brain Prize has been awarded to Michael A. Moskowitz, M.D., a professor of neurology at Harvard Medical School at the Massachusetts General Hospital, Charlestown, who also is supported by an NIH grant.

8 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

African American breast cancer survivors need to be better informed about CVD risk

African American breast cancer survivors are four times more likely to die from breast cancer than women of all other races and ethnicities, and they have a disproportionately high rate of death from cardiovascular disease (CVD).

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

ACTIV-3 clinical trial evaluating investigational COVID-19 therapies closes enrollment in two sub-studies

The ACTIV-3 clinical trial, which is evaluating the safety and efficacy of investigational therapeutics for COVID-19 in hospitalized patients, has closed enrollment in two sub-studies: one examining the investigational monoclonal antibody therapy VIR-7831, and another evaluating the investigational combination monoclonal antibody therapy containing BRII-196 and BRII-198.

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

KHN’s ‘What the Health?’: Good and not-so-good news on Covid

There's good news and bad news on Covid-19 this week. On the one hand, several million doses of the one-shot Johnson & Johnson vaccine authorized by the FDA for emergency use are already going into the arms of people around the nation.

4 Mar 2021

MDI Biological Laboratory receives grant to improve access to safe drinking water

The MDI Biological Laboratory will collaborate with the Maine Center for Disease Control and Prevention, an office of the state Department of Health and Human Services, on a five-year grant from the federal Centers for Disease Control and Prevention, to improve access to safe drinking water in Maine.

3 Mar 2021

The benefits and risks of using online health forums and services

The internet provides a major source of exchanging health information through online portals and new media. Internet users can access health sites and online forums to obtain health information.

2 Mar 2021

Biological activity-based modeling offers a new approach for drug discovery

Assessing a drug compound by its activity, not simply its structure, is a new approach that could speed the search for COVID-19 therapies and reveal more potential therapies for other diseases.

2 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 issues EUA for third COVID-19 vaccine

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

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

Critical Path Institute and global partners establish Ataxia Consortium

Critical Path Institute (C-Path) today announced the launch of the Critical Path to Therapeutics for the Ataxias (CPTA) Consortium, a public-private partnership focused on optimizing clinical trials for inherited ataxias.

27 Feb 2021

KHN’s ‘What the health?’: Staffing up at HHS

More than a month into President Joe Biden’s term, nominees to fill some of the top posts at the Department of Health and Human Services are finally getting confirmation hearings in the Senate, starting with the nominee for secretary, California Attorney General Xavier Becerra.

26 Feb 2021

Health and Human Services News and Research

Scientists receive the Brain Prize for groundbreaking contributions to novel migraine therapies

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

FDA issues emergency use authorization for T-Detect COVID Test

African American breast cancer survivors need to be better informed about CVD risk

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

ACTIV-3 clinical trial evaluating investigational COVID-19 therapies closes enrollment in two sub-studies

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

KHN’s ‘What the Health?’: Good and not-so-good news on Covid

MDI Biological Laboratory receives grant to improve access to safe drinking water

The benefits and risks of using online health forums and services

Biological activity-based modeling offers a new approach for drug discovery

FDA clears new robotically-assisted surgical device for transvaginal hysterectomy

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

FDA issues EUA for third COVID-19 vaccine

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

Critical Path Institute and global partners establish Ataxia Consortium

KHN’s ‘What the health?’: Staffing up at HHS

Event guide: 6th Operationalize Expanded Access Programs Summit East eBook

Advancing Intracellular Delivery with LumiPore®

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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