Posts filtered by tags: U.S. Food and Drug Administration[x]


 

Marijuana Use, Prohibited Persons & Explosives : ATF Comments

Marijuana Use, Prohibited Persons & Explosives : ATF Comments Bureau of Alcohol, Tobacco, Firearms and Explosives ( ATF ) Washington. DC – -(Ammoland.com)- ATF has received a number of inquiries regarding the use of marijuana for medicinal and recreational purposes and its applicability to Federal explosives laws. A number of States have passed legislation allowing the use of marijuana for medicinal or recreational purposes, and some of these States issue a card authorizing such use. Fede...
Tags: Shooting Industry News, ATF, Explosives, Marijuana


EU Regulator Prepares to Issue Advice on Use of J&J Vaccine

Experts at the European Medicines Agency are preparing to present the conclusions of their investigation  into possible links between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual clotting disorders detected in the U.S. Last week, Johnson & Johnson halted the European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases were examined.


EU Drug Regulator Prepares to Issue Advice on J&J COVID Shot

Experts at the European Medicines Agency are preparing to present the conclusions of their investigation  into possible links between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual clotting disorders detected in the U.S. Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases were examined.


FDA revokes EUA for monoclonal antibody therapy bamlanivimab to treat patients with COVID-19

Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
Tags: Health, Fda, U S Food and Drug Administration, EUA


FDA approves immunotherapy for first-line treatment of advanced gastric cancer

Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
Tags: Health, Fda, U S Food and Drug Administration


Experimental antiviral for COVID-19 effective in hamster study

The experimental antiviral drug MK-4482 significantly decreased levels of virus and disease damage in the lungs of hamsters treated for SARS-CoV-2 infection, according to a new study from NIH scientists. MK-4482, delivered orally, is now in human clinical trials. Remdesivir, an antiviral drug already approved by the U.S. Food and Drug Administration for use against COVID-19, must be provided intravenously, making its use primarily limited to clinical settings.
Tags: Science, Nih, U S Food and Drug Administration


LA County coronavirus numbers dip below those of pandemic’s early days

As Los Angeles County is forced to scale back on one-shot inoculations amid Johnson & Johnson’s woes, the region continues on a downward slope of coronavirus cases, deaths and hospitalizations. Public health officials reported 57 deaths and 411 cases in the county on Wednesday, April 14, bringing the total lives lost to 23,553, and total cases to 1,226,964. There are 518 people currently hospitalized, with 123 of them in intensive care, according to state data that reports a day ahead of L.A. Co...
Tags: Health, News, California, Government, Los Angeles, Sport, Soccer, Community, Pfizer, Lausd, Pasadena, Centers For Disease Control And Prevention, Los Angeles County, U S Food and Drug Administration, Johnson Johnson, Ferrer


We're creating pigs with human immune systems to study illness

The U.S. Food and Drug Administration requires all new medicines to be tested in animals before use in people. Pigs make better medical research subjects than mice, because they are closer to humans in size, physiology and genetic makeup. In recent years, our team at Iowa State University has found a way to make pigs an even closer stand-in for humans. We have successfully transferred components of the human immune system into pigs that lack a functional immune system. This breakthrough has the ...
Tags: Medicine, Medical Research, Innovation, Disease, National Institutes of Health, Health Care, Committee, U S Food and Drug Administration, Iowa State, Ames Iowa, Iowa State University, Kansas State University, Jason Ross, Human body, Jack Dekkers, Raymond Rowland


LA County to temporarily halt J&J vaccine following national recommendation

Public health officials in Los Angeles County will stop administering the Johnson & Johnson vaccine after reports that six women from the ages of 18 to 48 developed unusual blot clots. The pause was recommended by both the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention on Tuesday, April 13. L.A. County public health officials said in a statement Tuesday that they would follow the advice out of an abundance of caution. Long Beach and Pasadena, which both have...
Tags: News, California, Cdc, La, Los Angeles, Sport, Soccer, Long Beach, Fda, Pfizer, Pasadena, Centers For Disease Control And Prevention, Chinatown, Gavin Newsom, Los Angeles County, U S Food and Drug Administration


Memic raises $96M for its robot-assisted surgery platform

Memic, a startup developing a robotic-assisted surgical platform that recently received marketing authorization from the U.S. Food and Drug Administration, today announced that it has closed a $96 million Series D funding round. The round was led by Peregrine Ventures and Ceros, with participation from OurCrowd and Accelmed. The company plans to use the new funding to commercialize its platform in the U.S. and expand its marketing and sales efforts outside of the U.S., too. The company previousl...
Tags: Health, Startups, Hardware, Medicine, Tech, United States, Surgery, Fda, Telemedicine, Ourcrowd, General Partner, U S Food and Drug Administration, CEROS, MEMIC, Peregrine Ventures, Recent Funding


The Latest: Romanians protest restrictions as cases top 1M

By The Associated Press BUCHAREST — Marchers have taken to the streets of the Romanian capital of Bucharest to protest restrictive measures to fight the spread of COVID-19 even as new daily infections and deaths rise in the European Union nation. About 1,000 people converged Saturday on Victory Square and University Square, expressing frustration with an earlier curfew and shop closures that took effect at the end of March. Many demonstrators waved tri-color Romanian flags and chanted “Freedom!”...
Tags: Europe, Utah, New York, London, Mississippi, Supreme Court, California, Washington, Germany, India, Uncategorized, Narendra Modi, Sport, European Union, Iran, Ap


The Latest: Lawmakers aim to limit state emergency powers

By The Associated Press NEW YORK — State lawmakers across the U.S. are taking actions to limit the emergency powers of governors — not just in the current coronavirus pandemic, but for any future emergencies. The pushback is coming primarily from Republican lawmakers but is not entirely partisan. GOP lawmakers are targeting both Democratic and Republican governors. When the pandemic hit a year ago, many governors and their top health officials temporarily ordered residents to remain home, limite...
Tags: Europe, Utah, New York, London, Mississippi, California, Washington, Germany, India, Uncategorized, Narendra Modi, Sport, Iran, Ap, Britain, Soccer


The Latest: Vaccine shortages hitting poor countries

By The Associated Press LONDON — As many as 60 countries might be stalled at the first shots of their coronavirus vaccinations because nearly all deliveries through the global program are blocked until as late as June. The COVAX initiative is designed to provide vaccines to countries lacking the clout to negotiate on their own for scarce supplies. In the past two weeks, only 2 million doses were cleared for shipment to 92 countries through the program, the same amount injected in Britain alone. ...
Tags: Europe, Utah, New York, London, Mississippi, California, Germany, India, Uncategorized, Narendra Modi, Sport, Iran, Ap, Britain, Soccer, Food And Drug Administration


Pfizer Requests FDA To Approve COVID Vaccine For Kids Ages 12-15

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Tags: Boston, US, Fda, Pfizer, U S Food and Drug Administration, Pfizer Inc, Around the Nation, CBS Pfizer


FDA approves marketing of first AI-based device to assist clinicians during colon cancer screening

Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.
Tags: Health, Fda, U S Food and Drug Administration


Pfizer, BioNTech Seek U.S. Emergency Nod for COVID-19 Vaccine in Adolescents

(Reuters) - Pfizer Inc and its German partner BioNTech SE said on Friday they have requested the U.S. Food and Drug Administration to expand the...
Tags: Pfizer, U S Food and Drug Administration, Reuters Pfizer Inc, BioNTech SE


FDA announces new action plan for reducing dietary exposures to toxic elements for children

Protecting one of our most vulnerable populations, babies and young children, is among the U.S. Food and Drug Administration's highest priorities.
Tags: Health, Fda, U S Food and Drug Administration


Study reveals new mutations that make cancer resistant to KRAS-targeted therapies

A gene called KRAS is one of the most commonly mutated genes in all human cancers, and targeted drugs that inhibit the protein expressed by mutated KRAS have shown promising results in clinical trials, with potential approvals by the U.S. Food and Drug Administration anticipated later this year.
Tags: Health, U S Food and Drug Administration, KRAS


FDA authorizes use of Symbiotica COVID-19 Self-Collected Antibody Test System

The U.S. Food and Drug Administration today announced it has issued an emergency use authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
Tags: Health, Fda, U S Food and Drug Administration


The Latest: FDA Authorizes 2 Changes to Moderna’s Vaccine

The U.S. Food and Drug Administration has authorized two changes to Moderna’s COVID-19 vaccine that can provide extra doses from each vial.
Tags: Fda, U S Food and Drug Administration, Moderna


FDA investigates contributing factors for reported infections from reprocessed urological endoscopes

Today, the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes—devices used to view and access the urinary tract.
Tags: Health, Fda, U S Food and Drug Administration


FDA takes action to advance OTC and other screening test development

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.
Tags: Health, Fda, U S Food and Drug Administration


FDA decides to get more tests for screening asymptomatic individuals on the market

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.
Tags: Health, Fda, U S Food and Drug Administration


Scientists launch clinical trial of CRISPR gene correction therapy in patients with sickle cell disease

Scientists at UC San Francisco, UC Berkeley and UCLA have received U.S. Food and Drug Administration approval to jointly launch an early phase, first-in-human clinical trial of a CRISPR gene correction therapy in patients with sickle cell disease using the patient's own blood-forming stem cells.
Tags: Health, Ucla, U S Food and Drug Administration, UC San Francisco UC Berkeley


FDA waiver broadens the use of chlamydia and gonorrhea test at more point-of-care settings

Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
Tags: Health, Fda, U S Food and Drug Administration, Binx Health IO CT NG Assay


First cell-based gene therapy approved by the FDA for treating multiple myeloma

The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.
Tags: Health, Fda, U S Food and Drug Administration


FDA authorizes marketing of new device for short-term treatment of gait deficit in MS patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS).
Tags: Health, Fda, U S Food and Drug Administration


FDA approves non-surgical heart valve to treat patients with certain types of congenital heart disease

Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs.
Tags: Health, Fda, U S Food and Drug Administration


FDA approves new indication for drug to treat pediatric NDO patients

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.
Tags: Health, Fda, U S Food and Drug Administration


It’s time to scrap arbitrary COVID rules

Back in 2007, the Transportation Security Administration decided to “calm the checkpoints” at the nation’s airports. The TSA wanted its officers to observe travelers for suspicious behavior, such as showing signs of stress. The problem was that the way TSA officers were barking orders at everyone, from grandmothers to grade-schoolers, the only people at the airport who weren’t showing signs of stress were in their second hour of drinking at the terminal bar. So the government hired a top design ...
Tags: Florida, Supreme Court, California, Cdc, Opinion, Sport, Soccer, Tsa, Biden, Wall Street Journal, Transportation Security Administration, U S Food and Drug Administration, Centers for Disease Control, Board of Supervisors, Gottlieb, Ron DeSantis