Posts filtered by tags: Fda[x]


The 6 best at-home teeth whitening kits in 2021, according to dentists

Table of Contents: Masthead Sticky At-home teeth whitening kits help lift surface stains, but many are expensive and hurt your teeth. We asked six professional dentists to recommend their go-to at-home teeth-whitening products. Our top pick, Crest 3D White Professional Effects, is effective, simple, and fairly affordable. Wanting whiter teeth in a world of first impressions and social media needs no explanation. But which at-home teeth whitening kits won't make your pearlies sensitive afte...
Tags: Reviews, Health, New York, New York City, Trends, Hydrogen Peroxide, Features, Beauty, Buying Guide, Beverly Hills, Fda, Boulder, Teeth, Pap, Campbell, Waltham

New hope in the fight against prostate cancer: ‘We can win this war’

Alan Held’s scan showed more than 100 metastases. “They were literally speckled throughout my body, in my bones,” says the 64-year-old sales manager. Doctors told him he had stage-four prostate cancer and that it had spread. They started hormone therapy and chemotherapy tablets. It was September 2018. Seven months into treatment and Held’s cancer was still in his bones. His oldest son, Josh, did some research and found that there was another option, a promising treatment for prostate cancer call...
Tags: Health, News, California, Germany, Cancer, Sport, Frankfurt, Soccer, United States, Healthcare, Fda, Alan, Lake Tahoe, Josh, Linda, Vacaville

Should Medicare pay for Aduhelm?

In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer’s disease using the agency’s accelerated approval pathway, despite significant concerns about the evidence regarding the drug’s safety and effectiveness. The agency’s approval decision contradicted the recommendations of its own advisory committee, which voted overwhelmingly against the evidence presented in support of the drug. Soon after Read more… Should Medicare pay for Aduhelm? originally appeared in
Tags: Health, Policy, Fda, Neurology

What you need to know about the updated benzodiazepine boxed warning [PODCAST]

“The FDA recommended an updated boxed warning and standardization of product labels across the drug class. They recommended judicious prescribing and a gradual taper to mitigate withdrawal reactions. While I am optimistic about these changes, the updated warning doesn’t tell the whole story. After reviewing the newly updated Xanax Medication Guide, I have some concerns.” Read more… What you need to know about the updated benzodiazepine boxed warning [PODCAST] originally appeared in ...
Tags: Health, Podcast, Psychiatry, Fda, Medications, Xanax Medication Guide

Napa Doctor First Person To Face Federal Charges For Allegedly Falsifying COVID Vaccine Cards

NAPA (CBS13) — A Northern California doctor is the first person to face federal charges for allegedly giving out fake coronavirus vaccine cards. Dr. Julie Mazi, 41, of Napa, is accused of giving patients oral immunization pellets that she said contained small amounts of COVID and would offer life-long protection. Prosecutors say she then gave patients fake vaccine cards showing they received the Moderna shot. Mazi was charged with one count of wire fraud and one count of false statements related...
Tags: Health, News, California, Local, Syndicated Local, Fda, Napa, Doj, U S Department of Justice, Moderna, Mazi, HHS OIG, Lisa O Monaco, Coronavirus, COVID, Coronavirus Vaccine

Backed by $5M led by General Catalyst, Evvy launches a vaginal microbiome test to support women’s health research

Another US femtech startup has joined the race to build up data-sets to support research into and understanding of a range of health issues that can affect women. Evvy has today launched an at-home test kit for the vaginal microbiome. The user returns their swab to the startup for analysis — and gets detailed information and analysis of the microbes (fungi and bacteria) that are present in their vagina and may be associated with a variety of health concerns. Users of the test also get personaliz...
Tags: Health, Fundings & Exits, Startups, TC, US, United States, Fda, Microbiome, General Catalyst,, Jain, UCSF, Georgiadis, Bioinformatics, Margo Georgiadis, Femtech

Former FDA chief Scott Gottlieb warns of a Delta-driven virus peak at the end of September

FDA commissioner Scott Gottlieb Reuters Former FDA chief Scott Gottlieb warned of a COVID-19 peak at the end of September. The Delta variant would drive up cases over the next few months, he said. "The worst is yet to come," Gottlieb told Squawk Box on Wednesday. See more stories on Insider's business page. Dr. Scott Gottlieb, former head at the Food and Drug Administration, warned Wednesday that a Delta variant-fueled pandemic peak could hit the US in September. Gottlieb told Squawk ...
Tags: Health, Science, News, US, Trends, Healthcare, Delta, Food And Drug Administration, Fda, Pfizer, Vaccine, Squawk Box, Gottlieb, Scott Gottlieb, Centers for Disease Control and Prevention This, Coronavirus

UC Davis Researchers Using Tarantula Venom To Develop New Pain Reliever

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Tags: Health, News, Local, Seen On, Syndicated Local, Poison, Rosetta, Fda, UC Davis, Nguyen, Phuong Nguyen, Davis News, Vladimir Yarov, Yarovoy UC Davis Health, Yarov Yarovoy

California K-12 students who refuse to wear masks will be barred from campuses, state says

K-12 students in California who refuse to wear masks inside school buildings will be barred from campuses and offered “alternative educational opportunities,” state officials announced Monday, July 12. The exception will be for students granted exemptions, such as those whose medical condition makes it too difficult for them to keep a mask on. “Schools must exclude students from campus if they are not exempt from wearing a face covering under (California Department of Public Health) guidelines a...
Tags: Health, News, Education, California, Cdc, France, Sport, Soccer, Fda, Colton, Johnson Johnson, U S Centers for Disease Control and Prevention, LA County, California Department of Public Health, Top Stories LADN, Top Stories OCR

New approach that uses machine learning could transform drug development

Writing in the July 12, 2021 online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses machine learning to hunt for disease targets and then predicts whether a drug is likely to receive FDA approval.
Tags: Health, Fda, Nature Communications

LA County’s coronavirus cases top 1,000 for 4th straight day

For the fourth day in a row, the number of new COVID-19 infections reported in Los Angeles County topped 1,000 on Monday, July 12, as health officials also noted an uptick in outbreaks and urged adherence to infection-control measures at workplaces. Traditionally, daily COVID numbers have been dramatically lower on Sundays and Mondays due to lags in reporting test results from the weekend, meaning the infection numbers are likely larger than the numbers being released by the county. The county s...
Tags: Health, Business, News, California, France, Government, India, Los Angeles, Sport, Public Health, Soccer, United States, Delta, Community, Fda, Staples Center

New draft guidance addresses FDA’s oversight of foods covered by Systems Recognition Arrangement

In order to fulfill our public health mission and enhance the safety of imported foods in a global world, we must embrace new approaches that take into account the entire supply chain and its complexity.
Tags: Health, Fda, Systems Recognition Arrangement

Psilocybin and depression: “magic mushroom” drug could regrow lost brain connections

Stressed out mice have damaged neurons in their brains, and magic mushrooms can help them grow back.Neuronal damage, specifically a lack of dendritic spines, also has been observed in cases of depression in humans. So far, the findings are limited to mice, but the results hold promise for humans. Psychedelics, long demonized as substances used only by quacks and hippies, have been enjoying a renaissance in the biomedical community over the past few years. Even the FDA is getting in on the action...
Tags: Drugs, Mental Health, Brain, Depression, Innovation, Fda, Copenhagen, Yale University, Kwan, Alex Kwan

The FDA was wrong about Aduhelm

The Food and Drug Administration (FDA) negated the recommendation of its expert panel and approved Aduhelm to treat Alzheimer’s dementia (AD), contending that the possible benefit trumped the lack of evidence of efficacy. The FDA was inexcusably in error in making this decision. Aside from the likely lack of benefit, the use of this drug Read more… Find jobs at Careers by Search thousands of physician, PA, NP, and CRNA jobs now. Learn more.
Tags: Health, Fda, Neurology, Medications, Food and Drug Administration FDA, Meds, PA NP, CRNA

Does the FDA approval of aducanumab mark the return of science-based medicine?

The 20th century was an explosion of scientific innovation and discovery. The success of chemistry, physics and biology to produce things such as antibiotics, radiography and genetic analysis could not be ignored. Medicine is not now, nor has it ever been, a “science.” But over the past century, medicine became science-based. This means that while Read more… Find jobs at Careers by Search thousands of physician, PA, NP, and CRNA jobs now. Learn more.
Tags: Health, Fda, Neurology, Medications, Meds, PA NP, CRNA

FDA's new Cyclospora Prevention, Response and Research Action Plan released

As part of our ongoing efforts to combat foodborne illness and aligned with our New Era of Smarter Food Safety initiative, today, the U.S. Food and Drug Administration released the Cyclospora Prevention, Response and Research Action Plan.
Tags: Health, Fda, U S Food and Drug Administration

FDA revokes EUAs for non-NIOSH-approved respirators, decontamination systems

The following quote is attributed to Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health.
Tags: Health, Fda, NIOSH, Suzanne Schwartz, Center for Devices

FDA approves alternative component of chemotherapy regimen to treat acute lymphoblastic leukemia

Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.
Tags: Health, Fda, U S Food and Drug Administration

FDA releases results of ongoing testing efforts to assess the occurrence of PFAS in food supply

Today, the U.S. Food and Drug Administration is providing an update on its ongoing sampling and testing efforts designed to better understand the occurrence of per- and polyfluoroalkyl substances (PFAS) in the food supply.
Tags: Health, Fda, U S Food and Drug Administration

4G Clinical’s clinical trial management software attracts over $200M in new funding

The pandemic significantly changed how we do medical research, and now companies are trying to figure out what trends will stay and which ones will go. One that 4G Clinical is hoping will survive the pandemic is a need for speed and flexibility in therapeutics trials.  4G Clinical creates software to run the back-end of a clinical trial. That means randomizing patients into treatment and placebo groups, locating medicines and placebos, keeping the supply of those medicines stocked, and, at le...
Tags: Health, TC, Medicine, Boston, Tech, SaaS, Portland, World Health Organization, Fda, Pfizer, Biotech, Clinical Trials, Impala, ACME, Kelleher, Veeva

FDA's controversial decision to approve aducanumab for Alzheimer's treatment raises major ethical issues

The U.S. Food and Drug Administration's controversial decision to approve aducanumab for the treatment of Alzheimer's disease raises at least three major ethical issues that need to be addressed, states a new article in the Hastings Center Report:
Tags: Health, Fda, U S Food and Drug Administration

Immune response to FDA-approved vaccines is strong and potentially long-lasting

The first two COVID-19 vaccines authorized for emergency use by the Food and Drug Administration (FDA) employed a technology that had never before been used in FDA-approved vaccines.
Tags: Health, Fda, Food and Drug Administration FDA

How much protection you get from one dose of the Pfizer, AstraZeneca, and Moderna vaccines, according to the best available data

Pfizer's COVID-19 vaccine. Getty Millions of people worldwide have had one shot of two-dose COVID-19 vaccines. Pfizer and Moderna's vaccines are likely 80% effective against symptomatic COVID-19 after one dose. A single AstraZeneca shot is probably at least 70% effective at preventing symptomatic COVID-19. See more stories on Insider's business page. More than 179 million Americans and more than 44 million Britons have received their first dose of a two-shot COVID-19 vaccine.Th...
Tags: Health, UK, England, Science, India, Israel, US, Trends, Joe Biden, Data, South Africa, Healthcare, Food And Drug Administration, Brazil, Astrazeneca, Evans

Some experts who had Johnson & Johnson's single-dose vaccine are now getting extra shots of Pfizer or Moderna to try to protect against the Delta variant

A pharmacist at the Hartford Hospital in Hartford, Connecticut, fills a syringe with the Johnson & Johnson COVID-19 vaccine. Joseph Prezioso/Getty Images Some experts who got Johnson & Johnson's one-dose vaccine are topping it up with a dose of Pfizer or Moderna. They did it for extra protection against the fast-spreading Delta coronavirus variant, they said. The FDA and CDC don't recommend getting an extra shot, after a J&J vaccine or otherwise. See more stories on Insider's b...
Tags: Health, UK, Science, News, Cdc, US, Trends, Joe Biden, Healthcare, Delta, Astrazeneca, Fda, Pfizer, Vaccine, Johnson, Anthony Fauci

Musculoskeletal medical startups race to enter personalized health tech market

As the pandemic unevenly roars on, Emily Melton, founder and managing partner of Threshold VC, is reflecting on a previous public health crisis: the Spanish Flu. She says the response just over a century ago prompted the rise of interventional medicine — treating illness through surgery or medicine only after symptoms manifest. Today, interventional medicine is the dominant mindset in Western healthcare. And, Melton, a lead investor in health tech startups including Livongo, Tia, and Calibrate, ...
Tags: Health, Startups, TC, California, Tech, Healthcare, Venture Capital, Silicon Valley, Fda, Health Tech, Digital Health, Bessemer, MSK, Melton, John Hopkins, Avi Dorfman

FDA issues draft guidance encouraging rational expanded patient eligibility for oncology clinical trials

Today, the FDA issued a draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials, regardless of whether they have received existing alternative treatment options.
Tags: Health, Fda

FDA to add warning about rare heart inflammation to Pfizer and Moderna vaccines

US found link between vaccines and cases of inflammation in adolescents and young adults, but say benefits outweigh risksThe US Food and Drug Administration will add a warning to the Covid vaccines produced by Pfizer/BioNTech and Moderna about rare cases of heart inflammation in adolescents and young adults, the agency announced on Wednesday.US Centers for Disease Control and Prevention advisory groups, meeting to discuss reported cases of the heart condition after vaccination, found the inflamm...
Tags: Health, US, US news, Fda, Vaccines and immunisation, Pfizer, US Food and Drug Administration, US Centers for Disease Control and Prevention, Moderna, Coronavirus, Pfizer BioNTech

FDA approves oral pellets to treat children with venous thromboembolism

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days.
Tags: Health, Fda, U S Food and Drug Administration, Pradaxa

How Pfizer and BioNTech made history with their vaccine

Wondering how Pfizer and partner BioNTech developed a COVID-19 vaccine in record time without compromising safety? Dr Bill Gruber, SVP of Pfizer Vaccine Clinical Research and Development, explains the process from start to finish."I told my team, at first we were inspired by hope and now we're inspired by reality," Dr Gruber said. "If you bring critical science together, talented team members together, government, academia, industry, public health officials—you can achieve what was previously th...
Tags: Health, Science, Technology, Innovation, Fda, Pfizer, Vaccines, Gruber, Food and Drug Administration FDA, EUA, BioNtech, Bill Gruber, Pfizer Vaccine Clinical Research and Development

FDA approves antihistamine nasal spray for over-the-counter use

The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch.
Tags: Health, Fda, U S Food and Drug Administration

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