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Management: Food and Drug Administration (FDA)
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Total 1725 results found since Jan 2013.
Nevada Halts Use of Rapid Coronavirus Tests in Nursing Homes
Two tests made by Quidel and BD repeatedly delivered false-positive results, prompting the state to stop using them.
Source: NYT Health - October 7, 2020 Category: Consumer Health News Authors: Katherine J. Wu Tags: Tests (Medical) Coronavirus (2019-nCoV) Elderly Nursing Homes Elder Care Laboratories and Scientific Equipment Abbott Laboratories Becton Dickinson & Food and Drug Administration Nevada your-feed-science your-feed-health your-fee Source Type: news
Coronavirus Vaccine: Pfizer Says It Won ' t Seek Authorization Before Mid-November
Friday ’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.
Source: NYT Health - October 16, 2020 Category: Consumer Health News Authors: Katie Thomas and Noah Weiland Tags: your-feed-science Clinical Trials Vaccination and Immunization United States Politics and Government Presidential Election of 2020 Coronavirus (2019-nCoV) Food and Drug Administration Pfizer Inc Bourla, Albert Trump, Donald J Source Type: news
Guidelines for approving a coronavirus vaccine will be the focus of FDA advisers meeting Thursday
A Food and Drug Administration panel is scheduled to hold a milestone meeting to kick off the complicated process of vetting the safety and effectiveness of vaccines against the novel coronavirus.
Source: Washington Post: To Your Health - October 22, 2020 Category: Consumer Health News Authors: Laurie McGinley Source Type: news
FDA approves Gilead's remdesivir as a treatment for coronavirus patients
On Thursday, the US Food and Drug Administration (FDA) announced it had given full approved the antiviral drug remdesivir as a treatment for patients infected with the novel coronavirus.
Source: the Mail online | Health - October 22, 2020 Category: Consumer Health News Source Type: news
Understanding Severe Acute Respiratory Syndrome Coronavirus 2 Replication to Design Efficient Drug Combination Therapies
Background: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its disease CO VID-19 has strongly encouraged the search for antiviral compounds. Most of the evaluated drugs against SARS-CoV-2 derive from drug repurposing of Food and Drug Administration-approved molecules. These drugs have as target three major processes: (1) early stages of virus-cell interaction, (2) viral proteases, and (3) the viral RNA-dependent RNA polymerase.Summary: This review focused on the basic principles of virology and pharmacology to understand the importance of early stages of virus-cell interaction as therap...
Source: Intervirology - October 23, 2020 Category: Virology Source Type: research
Coronavirus vaccine final-stage testing to restart in US
AstraZeneca and Johnson& Johnson get go-ahead from Food and Drug Administration after pausing studies when volunteers became illTwo drugmakers have announced the resumption of US testing of their Covid-19 vaccine candidates.Testing of AstraZeneca ’s vaccine candidate had been halted since early September, while Johnson& Johnson ’s vaccine studywas paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.Continue reading...
Source: Guardian Unlimited Science - October 24, 2020 Category: Science Authors: Associated Press Tags: Coronavirus Infectious diseases Science World news Medical research Source Type: news
Moderna May Know If COVID-19 Vaccine Works By End Of November
(CNN) — Moderna has finished accumulating data for a first analysis of its COVID-19 vaccine and expects to have an announcement on the vaccine’s efficacy by the end of the month, the company said in a statement Wednesday.
Pfizer announced Monday that its coronavirus vaccine is more than 90% effective.
Moderna, which has its headquarters in Cambridge, is conducting a clinical trial of 30,000 participants, with half receiving the vaccine and half receiving a placebo, which is a shot of saline that does nothing.
In order for Moderna’s vaccine to be considered for authorization by the US Food and Drug Adminis...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 12, 2020 Category: Consumer Health News Authors: CBS Boston Tags: Covid-19 Boston, MA Healthcare Status News Syndicated CBSN Boston Cambridge News Coronavirus Moderna Moderna Therapeutics Source Type: news
Moderna May Know How Effective COVID-19 Vaccine Is By End Of Month
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 12, 2020 Category: Consumer Health News Authors: CBS Boston Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Healthwatch Syndicated CBSN Boston Cambridge News Coronavirus Moderna Moderna Therapeutics Source Type: news
Early Data Show Moderna ’s Coronavirus Vaccine Is 94.5% Effective
Moderna is the second company to report preliminary results from a large trial testing a vaccine. But there are still months to go before it will be widely available to the public.
Source: NYT Health - November 16, 2020 Category: Consumer Health News Authors: Denise Grady Tags: Vaccination and Immunization Drugs (Pharmaceuticals) Politics and Government Coronavirus (2019-nCoV) RNA (Ribonucleic Acid) Research Biomedical Advanced Research and Development Authority Food and Drug Administration Moderna Inc National Source Type: news
New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective
The company said it planned to apply for emergency approval from the Food and Drug Administration “within days.”
Source: NYT Health - November 18, 2020 Category: Consumer Health News Authors: Katie Thomas Tags: your-feed-science Clinical Trials Vaccination and Immunization Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) RNA (Ribonucleic Acid) BioNTech SE Pfizer Inc Food and Drug Administration Moderna Inc your-feed-healthcare Source Type: news
Bill Gates, la Covid-19, et le combat pour vacciner la plan ète
Le milliardaire travaille avec l ’OMS, les groupes pharmaceutiques et plusieurs ONG pour dompter le coronavirus à travers le monde, y compris dans les pays les plus pauvres. Réussiront-ils?
Source: NYT Health - November 25, 2020 Category: Consumer Health News Authors: Megan Twohey and Nicholas Kulish Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Gates, Bill Fauci, Anthony S AstraZeneca PLC Coalition for Epidemic Preparedness Innovations Food and Drug Administration Microsoft Corp Pfizer Inc Gates, Bill and Melinda, Foundation Source Type: news
Bill Gates, la Covid-19 et le combat pour vacciner la plan ète
Le milliardaire travaille avec l ’OMS, les groupes pharmaceutiques et plusieurs ONG pour dompter le coronavirus à travers le monde, y compris dans les pays les plus pauvres. Réussiront-ils?
Source: NYT Health - November 26, 2020 Category: Consumer Health News Authors: Megan Twohey and Nicholas Kulish Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Gates, Bill Fauci, Anthony S AstraZeneca PLC Coalition for Epidemic Preparedness Innovations Food and Drug Administration Microsoft Corp Pfizer Inc Gates, Bill and Melinda, Foundation Source Type: news
The U.K. Asks Its Regulator to Assess the AstraZeneca and Oxford University Coronavirus Vaccine After Dosing Errors
LONDON — The British government said Friday it has formally asked the country’s medicines regulator to assess whether a coronavirus vaccine developed by AstraZeneca and Oxford University should be authorized for use.
The step comes amid questions about preliminary results from trials of the jab, after the company and the university acknowledged that the most encouraging part of their findings stemmed from a dosing error.
U.K. Health Secretary Matt Hancock said he had asked the Medicines and Healthcare Products Regulatory Agency to determine whether the vaccine “meets rigorous safety standards.”
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Source: TIME: Health - November 27, 2020 Category: Consumer Health News Authors: JILL LAWLESS / AP Tags: Uncategorized COVID-19 overnight wire Source Type: news
Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine
The first shots could be given as early as Dec. 21, if authorization is granted.
Source: NYT Health - November 30, 2020 Category: Consumer Health News Authors: Denise Grady Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Research RNA (Ribonucleic Acid) Food and Drug Administration Moderna Inc National Institute of Allergy and Infectious Diseases your-feed-healthcare Source Type: news
Moderna Covid vaccine has 94% efficacy, final results confirm
US company submits data to start approval process with regulators around the worldCoronavirus – latest updatesSee all our coronavirus coverageFinal results from the trials of Moderna ’s vaccine against Covid-19 confirm it has 94% efficacy and nobody who was vaccinated with it developed severe disease, said the company, kickstarting the approval process with regulators around the world.The US company is submitting the data to the regulators in the US, Europe and the UK for an emergency licence. It expects the Food and Drug Administration in the US to consider it at its meeting on 17 December, Moderna said.Continue reading...
Source: Guardian Unlimited Science - November 30, 2020 Category: Science Authors: Sarah Boseley Global health editor Tags: Coronavirus Infectious diseases Medical research Microbiology World news Science US news UK news Source Type: news
