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Management: Food and Drug Administration (FDA)
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Coronavirus disease 2019 vaccination in women and assisted reproductive technology
The use of medical interventions is based on a balance between effectiveness and safety. Medical interventions that are not effective should not be used. For interventions that have side effects, the expected frequency and severity of these side effects should be balanced against the expected benefit of the treatment. Although doctors can advise on treatment, the final decision is made by the individual who will receive the treatment. For drugs, including vaccines, the assessment of effectiveness and safety is formalized and undertaken by regulatory authorities, such as the Food and Drug Administration in the United States...
Source: Fertility and Sterility - March 22, 2023 Category: Reproduction Medicine Authors: Ben W. Mol, Michelle L. Giles Tags: Reflections Source Type: research
Paxlovid Moves Closer to Full FDA Approval
WASHINGTON — Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration.
The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021. The agency has the final say on giving Pfizer’s drug full approval and is expected to decide by May.
A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for high-risk adults with COVID-19 who are more likely to face hospitalization and death due to the ...
Source: TIME: Health - March 16, 2023 Category: Consumer Health News Authors: Matthew Perrone/AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news
F.D.A. Advisers Endorse Paxlovid ’s Benefits as a Covid Treatment
While an agency analysis did find signs of Covid “rebound,” the drug significantly reduces hospitalizations and deaths, researchers said.
Source: NYT Health - March 16, 2023 Category: Consumer Health News Authors: Carl Zimmer and Christina Jewett Tags: Food and Drug Administration Pfizer Inc Coronavirus (2019-nCoV) Paxlovid (Drug) Drugs (Pharmaceuticals) United States Source Type: news
Florida surgeon general ’s Covid vaccine claims harm public, health agencies say
‘Fueling vaccine hesitancy undermines effort’ to protect lives, warns letter to Dr Joseph Ladapo sent by FDA and CDCUS health agencies have sent a letter to the surgeon general of Florida, warning that his claims about Covid-19 vaccine risks are harmful to the public.The letter was sent to Joseph Ladapo on Friday by the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). It was a response to a letter Ladapo wrote to the agencies last month, expressing concerns about what he described as adverse effects from Covid vaccines.Continue reading...
Source: Guardian Unlimited Science - March 12, 2023 Category: Science Authors: Associated Press in Orlando, Florida Tags: Florida Coronavirus Vaccines and immunisation Health Infectious diseases Science US news Source Type: news
First combination home test for flu and covid cleared by the FDA
The Food and Drug Administration on Friday authorized the first combination test for the flu and the coronavirus that is fully performed at home, giving consumers a convenient way to determine which pathogen may be causing their respiratory illnesses. The agency granted emergency use authorization…#luciracovid19flutest #rsv #fda #lucira #tamiflu #jeffshuren #shiraidoron #tuftsmedicalcenter #boston #doron
Source: Reuters: Health - February 25, 2023 Category: Consumer Health News Source Type: news
MRI for all: Cheap portable scanners aim to revolutionize medical imaging
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The patient, a man in his 70s with a shock of silver hair, lies in the neuro intensive care unit (neuro ICU) at Yale New Haven Hospital. Looking at him, you’d never know that a few days earlier a tumor was removed from his pituitary gland. The operation didn’t leave a mark because, as is standard, surgeons reached the tumor through his nose. He chats cheerfully with a pair of research associates who have come to check his progress with a new and potentially revolutionary device they are testing.
The cylind...
Source: Science of Aging Knowledge Environment - February 23, 2023 Category: Geriatrics Source Type: research
New ‐onset retroperitoneal fibrosis following COVID‐19 mRNA vaccination: Coincidental or vaccine‐induced phenomenon?
AbstractThe Pfizer-BioNTech mRNA vaccine is a US Food and Drug Administration-approved coronavirus disease 2019 (COVID-19) vaccine. Although it is reported to be safe and effective, immune dysregulation leading to autoimmunity has become an area of concern. Retroperitoneal fibrosis (RPF) is an immune-mediated fibroinflammatory disease characterized by the deposition of fibrous tissues, primarily around the abdominal aorta and iliac arteries. Herein, we report a case of RPF following Pfizer BioNTech COVID-19 mRNA vaccination. To the best of our knowledge, there have been no published reports on RPF after COVID-19 mRNA vacci...
Source: International Journal of Rheumatic Diseases - February 23, 2023 Category: Rheumatology Authors: Hirut Yadeta Ture,
Na Ri Kim,
Eon Jeong Nam Tags: CASE REPORT Source Type: research
Application of Cell Penetrating Peptides as a Promising Drug Carrier to Combat Viral Infections
Mol Biotechnol. 2023 Jan 31. doi: 10.1007/s12033-023-00679-1. Online ahead of print.ABSTRACTNovel effective drugs or therapeutic vaccines have been already developed to eradicate viral infections. Some non-viral carriers have been used for effective drug delivery to a target cell or tissue. Among them, cell penetrating peptides (CPPs) attracted a special interest to enhance drug delivery into the cells with low toxicity. They were also applied to transfer peptide/protein-based and nucleic acids-based therapeutic vaccines against viral infections. CPPs-conjugated drugs or vaccines were investigated in several viral infectio...
Source: Herpes - January 31, 2023 Category: Infectious Diseases Authors: Niloofar Khairkhah Ali Namvar Azam Bolhassani Source Type: research
Second Phase of the NIH Preprint Pilot Launched
Today, we are pleased to announce the launch of the second phase of the NIH Preprint Pilot with the addition of more than 700 new preprint records to PubMed Central (PMC) and PubMed. This second phase expands the scope of the Pilot to include preprints resulting from all NIH-funded research. Eligible preprints are those acknowledging direct support of an NIH award or authored by NIH staff and posted to bioRxiv, medRxiv, arXiv, or Research Square, on or after January 1, 2023. NLM will automatically include the full text of the preprint (as license terms allow) and associated citation information in PMC and PubMed, respectiv...
Source: PubMed Central News - January 30, 2023 Category: Databases & Libraries Source Type: news
Viruses, Vol. 15, Pages 392: Respiratory Viruses and Virus-like Particle Vaccine Development: How Far Have We Advanced?
uan
With technological advancements enabling globalization, the intercontinental transmission of pathogens has become much easier. Respiratory viruses are one such group of pathogens that require constant monitoring since their outbreak leads to massive public health crises, as exemplified by the influenza virus, respiratory syncytial virus (RSV), and the recent coronavirus disease 2019 (COVID-19) outbreak caused by the SARS-CoV-2. To prevent the transmission of these highly contagious viruses, developing prophylactic tools, such as vaccines, is of considerable interest to the scientific community. Virus-like particles...
Source: Viruses - January 30, 2023 Category: Virology Authors: Ki-Back Chu Fu-Shi Quan Tags: Review Source Type: research
FDA pulls authorization for COVID antibody treatment over lack of effectiveness
Evusheld, the preventative monoclonal antibody treatment for COVID-19, has lost its emergency use authorization in the U.S. as it is most likely not effective against the strains of the coronavirus currently circulating. The announcement from the Food and Drug Administration (FDA) comes weeks…#evusheld #fda #astrazeneca #molnupiravir
Source: Reuters: Health - January 27, 2023 Category: Consumer Health News Source Type: news
FDA ends emergency use authorization for COVID-19 drug Evusheld
The Food and Drug Administration on Thursday withdrew emergency use authorization for the COVID-19 drug Evusheld because of its lack of effectiveness against some of the more widespread coronavirus variants.
Source: Health News - UPI.com - January 27, 2023 Category: Consumer Health News Source Type: news
With rise of new coronavirus variants, FDA halts authorization of Evusheld
The US Food and Drug Administration on Thursday halted the emergency use authorization of Evusheld because it does not appear to protect against Covid-19 from viral variants currently circulating in the United States.
Source: CNN.com - Health - January 27, 2023 Category: Consumer Health News Source Type: news
FDA Experts Vote to Make All COVID-19 Vaccines and Boosters Bivalent
In a unanimous decision, all 21 voting members of the U.S. Food and Drug Administration’s (FDA) vaccine committee recommended that the U.S. start using the same COVID-19 virus strain in all of the COVID-19 vaccines, including primary and booster doses.
That means the bivalent booster dose, which targets both the original SARS-CoV-2 strain and the Omicron BA.4/5 strains, would soon become the only type used for all primary shots and boosters.
The decision reflects a turning point in the pandemic. Until now, vaccine makers have tried to keep up with constantly evolving variants, but they’ve always been a few step...
Source: TIME: Health - January 27, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
US moves to simplify Covid vaccines into yearly dose to target variants
The FDA asked its scientific advisers on Thursday to help chalk out plan to move to a flu shot-like schedule for coronavirusThe US is poised to make Covid-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus.The Food and Drug Administration asked its scientific advisers on Thursday to help lay the groundwork for switching to once-a-year boosters for most Americans – and how and when to periodically update the shots’ recipe.Continue reading...
Source: Guardian Unlimited Science - January 27, 2023 Category: Science Authors: Associated Press Tags: Coronavirus US news Infectious diseases Vaccines and immunisation Pfizer Pharmaceuticals industry Science Source Type: news
