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Keyword: fda

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  • FDA Allows Temporary Import of Unapproved Chinese Cancer Drug to Ease U.S. Shortage

    06/03/2023 8:53:38 PM PDT · by nickcarraway · 21 replies
    CNBC ^ | FRI, JUN 2 2023 | Spencer Kimball
    -The U.S. Food and Drug Administration has given Qilu Pharmaceutical permission to ship cisplatin to the United States to ease a national cancer drug shortage. -The drug maker’s cisplatin injections are manufactured and marketed in China. Cisplatin is widely used in chemotherapy to treat testicular, lung, bladder, cervical and ovarian cancers. -The FDA earlier said it was considering allowing nonapproved drugs to be imported to alleviate the shortage. The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States,...
  • FDA approves first human trials for Elon Musk’s brain chip company Neuralink

    05/28/2023 6:33:46 AM PDT · by Roman_War_Criminal · 38 replies
    Life Site News ^ | 5/26/23 | Andreas Wailzer
    Elon Musk’s brain chip company Neuralink announced that the U.S. Food & Drug Administration (FDA) has approved its product for human trials. “This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” Musk’s company wrote in a tweet. “Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” Neuralink added. Neuralink has been a passion project for Musk since its founding in 2016. The tech mogul has stated in the...
  • FDA Bans Farmers from Caring for Their Own Animals Without Costly Vet Approval

    05/26/2023 3:01:59 PM PDT · by CFW · 90 replies
    PJMedia ^ | 5/26/23 | Megan Fox
    For the last, oh, I don’t know… forever… ranchers and farmers large and small have taken care of their livestock with antibiotics and antimicrobials that were available at farm stores. These medicines treat common illnesses and infections that people who own large animals and livestock are very familiar with and qualified to treat. They have been trusted to do so for as long as these medicines have been available. The first chicken antibiotics were introduced in 1948. Since then, there has been no call nor reason to regulate these items. Many farmers and ranchers tend to many of their animals’...
  • Vaccine-Injured Plaintiffs Sue Biden and Other Government Officials in First COVID Vax Lawsuit of its Kind

    05/25/2023 5:41:02 AM PDT · by MtnClimber · 16 replies
    American Greatness ^ | 24 May, 2023 | Debra Heine
    Six people who were harmed by COVID-19 injections are suing a slew of top Biden administration officials in the first lawsuit of its kind in the United States. In the complaint, filed on Monday, the plaintiffs allege the U.S. government colluded with social media companies to censor them when they posted factual information about their adverse reactions to the COVID vax, the Defender reported. The group says the government’s mass-censorship enterprise made it difficult for them to form support groups and find information about their injuries on social media. Defendants include Joe Biden, along with other top-ranking White House officials,...
  • ‘Sad Day for Babies and Mums’: FDA Panel Recommends Pfizer’s RSV Vaccine for Pregnant Women

    05/20/2023 2:22:13 PM PDT · by Roman_War_Criminal · 14 replies
    Children's Health Defense ^ | 5/19/23 | Michael Nevradakis, Ph.D.
    Advisers to the U.S. Food and Drug Administration (FDA) on Thursday recommended, by a vote of 10 to 4, that the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant women, despite questions about the vaccine’s safety. During Thursday’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, committee members and medical experts raised concerns about premature births identified during Pfizer’s clinical trials. The FDA is expected to issue a final decision on the vaccine in August. If approved, it would become the first RSV vaccine authorized for pregnant women. The Centers for Disease Control and Prevention (CDC) must...
  • Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

    05/18/2023 8:52:53 PM PDT · by bitt · 14 replies ^ | 5/18/2023 |
    Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. What You Need to Know: Most individuals, depending on age, previously vaccinated with a monovalent...
  • FDA Recommends People Only Take One mRNA COVID Vaccine, No More Boosters

    05/18/2023 8:45:31 PM PDT · by bitt · 15 replies
    BECKERNEWS.COM ^ | 5/18/2023 | kyle becker
    The U.S. Food and Drug Administration (FDA) has revised the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines to simplify the vaccination schedule for most individuals. The updated EUAs authorize the use of the current bivalent vaccines, covering the original strain and the omicron BA.4/BA.5 strains, for all doses given to individuals aged 6 months and older, including additional doses for certain populations. However, the monovalent versions of the Moderna and Pfizer-BioNTech vaccines are no longer authorized for use in the United States. Key Points to Note: Individuals previously vaccinated with a monovalent COVID-19 vaccine who...
  • FDA Approves First Pill Containing Human Feces

    05/09/2023 9:45:48 AM PDT · by SeekAndFind · 50 replies
    Epoch Times ^ | 05/09/2023 | Amy Denney
    Patients needing a fecal microbiota transplant for recurrent Clostridioides difficile (C. diff) infections now have the option of getting stool in pill form.Fecal transplant pills (artistic rendering) (Marc Bruxelle/Shutterstock)The U.S. Food and Drug Administration (FDA) recently approved Vowst, the first oral biologic drug for fecal microbiota that was shown in clinical trials to be as effective as fecal microbiota transplants given rectally. Biologic drugs are derived from blood, proteins, bacteria, and other living organisms.In a traditional fecal microbiota transplant or FMT, healthy donor stool is transferred into the colon of a patient, usually via colonoscopy or retention enema. Late last...
  • FDA: People Can Eat These Gene-Edited Pigs

    05/08/2023 12:12:06 PM PDT · by Red Badger · 18 replies ^ | MAY 8, 2023 10:34 AM ET | By David Wasson, Washington State University, Futurity
    Genetically-altered pigs are now on the menu. The United States Food and Drug Administration has authorized gene-edited pigs entrance into the food chain for human consumption—as German-style sausages. Gene-editing can make changes in an organism’s DNA that could occur in nature or through selective breeding but would take much longer without a tool like CRISPR. The FDA authorization is investigational, and limited to these particular pigs, but shows that gene-editing livestock to quickly produce desirable traits for improved food production is a viable strategy for helping feed the planet’s growing population. “It’s important for a university to set the precedent...
  • FDA warns against using certain Pilot At-Home COVID Tests due to contamination

    05/08/2023 10:23:10 AM PDT · by DallasBiff · 5 replies
    Richmond Times Dispathch ^ | 5/8/23 | Sean Mcguney
    The U.S. Food and Drug Administration is warning consumers to stop using and discard certain at-home COVID-19 tests because of "significant concerns of bacterial contamination." In a statement released Thursday, the FDA announced that the testing liquid in certain lots of SD Biosensor, Inc. Pilot COVID-19 At-Home Tests may be contaminated and should be disposed of immediately, without dumping the liquid down drains. Approximately 500,000 of the affected tests were distributed to CVS Health, with about 16,000 more being sent to Amazon, according to the FDA. SD Biosensor, Inc., initiated a recall of the affected tests, and the agency is...
  • It’s not popular to say, but Congress is the boss of the government

    05/05/2023 6:52:29 AM PDT · by Twotone · 13 replies
    Washington Examiner ^ | May 3, 2023 | Timothy P. Carney
    Should the Food and Drug Administration be allowed to approve whatever drugs it wants however it wants because the FDA is the expert on drug safety and efficacy? Should Congress defer to the Centers for Disease Control and Prevention and let stand a rule that is nonsensical and harmful? And here’s the general question: should executive branch agencies have broad authority to make whatever rules they want to accomplish their aims, as long as Congress hasn’t explicitly prohibited it? For too many politicians, regulators, and commentators, the answer is “yes.” “Believe in Science” or “Trust the Experts” has come to...
  • FDA approves world's first RSV vaccine, a shot for adults ages 60 and up...GSK's single-dose shot lowered the risk of severe illness by 94% in older adults.

    05/04/2023 6:11:25 AM PDT · by Red Badger · 146 replies
    NBC News ^ | May 3, 2023, 12:12 PM CDT / Updated May 3, 2023, 12:46 PM CDT By Aria Bendix
    The Food and Drug Administration on Wednesday approved the world's first RSV vaccine: a shot for adults ages 60 and up, made by pharmaceutical giant GSK. The milestone was decades in the making. Researchers first attempted to develop a vaccine for respiratory syncytial virus roughly 60 years ago. In a late-stage clinical trial, the single-dose shot lowered the risk of symptomatic illness by 83% and of severe illness by 94%. The Centers for Disease Control and Prevention must still recommend the vaccine before it becomes available to the public. A CDC advisory committee is scheduled to meet in June to...
  • FDA rejects experts' petition to relabel COVID vax as federal research confirms poor performance

    04/30/2023 10:20:08 PM PDT · by E. Pluribus Unum · 11 replies
    Just the News ^ | Updated: April 30, 2023 - 11:13pm | Greg Piper
    CDC Director Rochelle Walensky, former White House COVID adviser Anthony Fauci and especially President Biden repeatedly and falsely told Americans throughout 2021 that COVID-19 vaccines will protect them from infection and transmission.Despite this trail of official misinformation, the Food and Drug Administration has rejected a "petition for administrative action" from prominent medical researchers to order vaccine manufacturers to set the public record straight through revised labeling requirements on trial design, results and adverse events.The agency's rationale for inaction appears to undermine its own repeated warnings against treating COVID with ivermectin, an antiviral with a long safety record that few if...
  • Report 69: BOMBSHELL – Pfizer and FDA Knew in Early 2021 That Pfizer mRNA COVID “Vaccine” Caused Dire Fetal and Infant Risks, Including Death. They Began an Aggressive Campaign to Vaccinate Pregnant Women Anyway.

    04/30/2023 3:02:58 AM PDT · by E. Pluribus Unum · 57 replies
    Daily Clout ^ | April 29, 2023 | Amy Kelly
    April 29, 2023 • by Amy Kelly, Program Director of the War Room/DailyClout Pfizer Documents Analysis ProjectThe April 2023 batch of Pfizer clinical trial documents released under court order by the Food and Drug Administration (FDA) contains a shocking, eight-page document titled, “Pregnancy and Lactation Cumulative Review.” The data in the Cumulative Review are “…from the time of drug product development to 28-FEB-2021,” and Robert T. Maroko of the FDA approved the Review on April 20, 2021. It reveals that Pfizer and the FDA knew in early 2021 that Pfizer’s mRNA COVID vaccine, BNT162b2, resulted in:Adverse events in over 54%...
  • FDA: Vaccines Don’t Have to Prevent Infection or Transmission

    04/28/2023 7:06:14 AM PDT · by george76 · 41 replies
    Epoch Times ^ | Apr 25 2023 | Zachary Stieber,
    Vaccines don’t have to prevent infection or transmission to be cleared in the United States, the country’s top regulatory agency said in a new document. “It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission,” Dr. Peter Marks, a top official at the U.S. Food and Drug Administration (FDA), said in the document. Marks was writing as he rejected nearly all recommendations from a group of experts that advised the FDA to update the labels for the Pfizer and Moderna COVID-19 vaccines. Vaccines are traditionally known...
  • FDA: 'Vaccines Do Not Require Demonstration of the Prevention of Infection or Transmission'

    04/28/2023 7:29:50 AM PDT · by SeekAndFind · 79 replies
    PJ Media ^ | 04/28/2023 | Ben Bartee
    The now years-long Public Health™ campaign continues to reinvent the definition of “vaccine” in the service of accommodating Pfizer and Moderna’s mRNA injections. These shots utilize the genetic manipulation of cells to produce spike proteins rather than introducing an inactivated sample of the virus to induce an adaptive immune response — the mechanism of every vaccine in recorded history.The Animal Farm pigs did the same trick when they rewrote the Seven Commandments in the dark of night to excuse their abhorrent behavior.“Vaccines do not require demonstration of the prevention of infection or transmission,” according to U.S. Food and Drug Administration...
  • FDA Commissioner is lying again

    04/27/2023 8:58:44 PM PDT · by SeekAndFind · 4 replies
    Hotair ^ | 04/27/2023 | David Strom
    “Misinformation” is the Left’s new boogyman, up there with White Supremacists, carbon dioxide, and transphobes.We are supposed to believe that all these things are threats to human existence itself and that all of them must be ruthlessly suppressed in order to save humanity.Yeah, whatever.The FDA Commissioner Dr. Robert Califf has apparently been traveling the country making a rather amazing claim: that misinformation is the leading cause of death in America.If so, that’s pretty shocking. A number of studies suggest that medical errors may be the third-leading cause of death in America, resulting in 250,000 to 440,000 deaths a year, depending...
  • Drug used to halt puberty in children may cause lasting health problems

    04/26/2023 7:14:02 PM PDT · by NetAddicted · 31 replies ^ | 2/2/2017 | Christina Jewett
    For years, Sharissa Derricott, 30, had no idea why her body seemed to be failing. At 21, a surgeon replaced her deteriorated jaw joint. She’s been diagnosed with degenerative disc disease and fibromyalgia, a chronic pain condition. Her teeth are shedding enamel and cracking. None of it made sense to her until she discovered a community of women online who describe similar symptoms and have one thing in common: All had taken a drug called Lupron. Thousands of parents chose to inject their daughters with the drug, which was approved to shut down puberty in young girls but also is...
  • Kamala Harris Credits Make-Believe Federal Agency with Approving Abortion Pill

    04/24/2023 12:44:09 PM PDT · by ChicagoConservative27 · 13 replies
    Breitbart ^ | 02/24/2023 | KATHERINE HAMILTON
    Vice President Kamala Harris mistakenly credited a nonexistent federal agency with approving mifepristone in 2000, the first drug used in a two-drug medication abortion regimen. While speaking with Noticias Telemundo’s Vanessa Hauc in an interview that aired on Friday, Harris said the “Federal Drug Administration” is responsible for approving the abortion pill, Fox News reported. While the agency is not real, it would have the same abbreviation as the U.S. Food and Drug Administration (FDA), which did approve mifepristone:
  • Horowitz: Beware: The FDA is not retreating on the COVID jabs. It is reloading.

    04/22/2023 7:40:29 AM PDT · by bitt · 22 replies ^ | 4/21/2023 | daniel horowitz
    Some of you might have jumped with elation on Tuesday after hearing the news that the FDA had de-authorized the original series of COVID shots. What the agency is really doing, however, is reloading so it can enshrine the shots into the permanent immunization schedule and mix them with an ever-growing list of respiratory viral vaccines they are rolling out over the coming months. Now is the time for Congress to step on the gas pedal in opposing these shots, not tabling the issue as if it’s over. The FDA and CDC had a problem. There was no way to...