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Results for search "Food &, Drug Administration".

Health News Results - 297

FDA Tells Vaccine Makers to Update Boosters to Target Omicron Subvariants

The U.S. Food and Drug Administration announced Thursday that it has asked vaccine makers to update their COVID-19 booster shots to target the Omicron subvariants known as BA.4 and BA.5.

The two highly contagious subvariants now account for more than half of all new COVID cases in the United States...

Pool Neck Floats a Danger to Babies, FDA Warns

Neck floats marketed for babies to use in water can lead to serious injury or death, the U.S. Food and Drug Administration warned this week.

The inflatable plastic rings are especially dangerous for infants who have developmental delays or special needs, such as those with spina bifida, spinal muscular atrophy...

FDA Panel Supports Rollout of Tweaked Booster Shots From Moderna, Pfizer This Fall

A U.S. Food and Drug Administration advisory panel recommended on Tuesday that updated COVID-19 booster shots be used this fall to protect against Omicron and its highly contagious subvariants.

Because the virus mutates so quickly, the FDA may approve the new vaccine formulations, since COVID-19 cases are expected to surge again this winter. Tuesday's advisory panel approval speeds the p...

FDA Panel to Weigh Improved Booster Shots From Moderna, Pfizer

A U.S. Food and Drug Administration advisory panel will vote on Tuesday whether to recommend that updated COVID-19 booster shots be used this fall to protect against Omicron and its highl...

After Appeal, Court Rules Juul Can Still Sell E-Cigarettes for Now

A federal appeals court has ruled that for now, Juul Labs can continue to sell its electronic cigarettes on the U.S. market.

The Friday ruling came in response to the company seeking a temporary emergency hold while it appeals a ban of its products that was issue...

FDA Bans Juul E-Cigarettes From US Market

The U.S. Food and Drug Administration on Thursday ordered Juul Lab's to pull its e-cigarettes off the American market.

"Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine d...

FDA to Ban Juul E-Cigarettes From U.S. Markets

The U.S. Food and Drug Administration is poised to pull Juul Lab's e-cigarettes off the American market.

The decision, which follows a two-year review of reams of data presented by the vaping company, could come as early as Wednesday, sources told the Wall Street Journal.

The FDA has already

  • By Cara Murez HealthDay Reporter
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  • June 22, 2022
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  • With CDC Approval, COVID Shots For Kids Under 5 Ready for Delivery

    After a final sign-off on Saturday from the head of the U.S. Centers for Disease Control and Prevention, COVID-19 vaccines for children younger than 5 have finally become a reality.

    "This expands eligibility for vaccination to nearly 20 million additional children and means that all Americans ages 6 months and older are now eligible for vaccination," the agency said in a

  • Ernie Mundell and Robin Foster HealthDay Reporters
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  • June 20, 2022
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  • FDA Panel to Weigh Moderna Vaccine for Those Aged 6 to 17

    The U.S. Food and Drug Administration's vaccine advisory panel will decide on Tuesday whether to recommend the agency approve the emergency use of Moderna's COVID-19 vaccine in children aged 6 to 17.

    The panel will

    Another Study Finds Ivermectin Useless Against COVID-19

    Yet another study shows that ivermectin provides no benefits for COVID-19 patients, but researchers say they'll continue to study a higher dose of the drug.

    Even though the drug used for parasitic infections in animals and people is not approved by the U.S. Food and Drug Administration to treat COVID-19, some have touted it as a therapy against the disease. The

  • By Robert Preidt HealthDay Reporter
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  • June 13, 2022
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  • New ALS Drug Approved in Canada While Still Under FDA Review

    An experimental drug for the neurological disorder ALS was approved in Canada on Monday, but an ongoing evaluation of the treatment by the U.S. Food and Drug Administration has raised questions about its effectiveness.

    A condition of Hea...

    FDA Panel to Decide on Novavax COVID Vaccine

    A U.S. Food and Drug Administration vaccine advisory panel will weigh whether to recommend the emergency use of Novavax's COVID-19 vaccine on Tuesday.

    The decision will be based on

  • By Robert Preidt HealthDay Reporter
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  • June 7, 2022
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  • Abbott to Re-Open Baby Formula Plant on June 4

    Beginning June 4, Abbott Nutrition will restart producing baby formula at a shuttered factory that's been central to the ongoing shortage of infant formula in the United States, the company announced on Tuesday.

    The factory in Sturgis, Mich., has been closed since February for what the U.S. Food and Drug Administration called "insanitary conditions." In the first three months of the ye...

    Jif Peanut Butter Recalled Due to Possible Salmonella

    Some lots of Jif brand peanut butter are being recalled as health officials investigate a multistate outbreak of Salmonella illness tied to the products.

    Fourteen illnesses (including two hospitalizations) tied to the Salmonella Senftenberg strain of the bacteria have occurred in Arkansas, Georgia, Illinois, Massachusetts, Missouri, Ohio, North Carolina, New York, South ...

    Closed Baby Formula Plant May Reopen by Next Week

    A baby formula plant closed in February at the heart of the current U.S. shortage of the product could reopen as soon as next week, U.S. Food and Drug Administration Commissioner Dr. Robert Califf told House lawmakers on Thursday.

    The Abbott Nutrition's Michigan formula plant is the largest in the nation, and it was closed due to contamination issues.

    Earlier this week, the FDA...

    Underwear That Guards Against STDs During Oral Sex? FDA Says Yes

    The first underwear meant to protect against sexually transmitted infections during oral sex was approved by the U.S. Food and Drug Administration on Thursday.

    Lorals -- which are available as bikinis or shorties -- are made of vanilla-flavored latex about as thin as condom material and form a ...

    FDA Warns of Counterfeit Home COVID-19 Test Kits

    The U.S. Food and Drug Administration is warning Americans to watch out for phony at-home, over-the-counter COVID-19 tests that look a lot like the real things.

    The counterfeit test kits may put you at risk of unknowingly spreading the disease or not seeking appropriate medical treatment, the agency cautions.

    The phonies "are made to look like authorized tests so the users will thi...

    FDA Proposes Ban on Menthol Cigarettes, Flavored Cigars

    The U.S. Food and Drug Administration on Thursday released proposed rules — first announced a year ago — to ban menthol cigarettes and flavored cigars.

    "The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit," U.S. Health and Human Services Secretary Xavier Becerra said in an FDA

  • Dennis Thompson HealthDay Reporter
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  • April 28, 2022
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  • FDA Warns 12 Companies About Skin Lightening Products

    Twelve companies have been issued warning letters about selling over-the-counter skin lightening products containing hydroquinone, the U.S. Food and Drug Administration announced Tuesday.

    The products are unapproved drugs that are not recognized as safe and effective, according to

  • By Robert Preidt HealthDay Reporter
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  • April 20, 2022
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  • Who Are the New 'Patient Influencers' on Social Media?

    Disability activist Gem Hubbard regularly shares her insights about life in a wheelchair with more than 75,000 Instagram followers, under the handle @wheelsnoheels_, and her YouTube videos boast more than 3.7 million hits.

    Hubbard, who hails from the U.K., is "increasingly known internationally for her work in furthering the horizons of people with and without disabilities,"

  • Dennis Thompson HealthDay Reporter
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  • April 15, 2022
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  • FDA Approves First Breath Test for COVID

    People who suspect they may have COVID-19 could soon find out with a simple breath test that delivers results in three minutes.

    On Thursday, the U.S. Food and Drug Administration granted an emergency use authorization for a device called the InspectIR Covid-19 Breathalyzer. The test, which must be administered by a trained operator, demonstrates a high degree of accuracy while taking up n...

    New Law Allows FDA to Police E-Cigs Made With Synthetic Nicotine

    A new law will ensure that vaping companies making electronic cigarettes using synthetic nicotine, in fruit flavors that appeal to teenagers, can be regulated by the U.S. Food and Drug Administration.

    When the law took effect Thursday,...

    J&J to Pay Over $300 Million in Pelvic Mesh Case

    Johnson & Johnson must pay $302 million to the state of California for deceptive marketing of pelvic mesh implants for women, an appeals court ruled on Monday.

    However, that is $42 million less than the $344 million originally assessed in 2020.

    Superior C...

    FDA Warns of U.S. Norovirus Cases Linked to Canadian Oysters

    The United States and Canada are investigating a multistate outbreak of norovirus illnesses linked to raw oysters from Canada.

    Restaurants and retailers should not serve or sell these potentially contaminated raw oysters, which were harvested in the south and central parts of Baynes Sound, British Columbia, Canada, the U.S. Food and Drug Administration said.

  • By Cara Murez HealthDay Reporter
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  • April 5, 2022
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  • FDA Reviewers Give Thumbs Down to New ALS Drug

    Despite months of intense lobbying by patient advocates, federal health officials on Monday posted a largely negative review of an experimental drug for the devastating illness known as amyotrophic lateral sclerosis (ALS).

    In an analysis of Amylyx Pharmaceuticals' drug, known for now only as

  • Dennis Thompson and Robin Foster
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  • March 29, 2022
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  • Stakes Are High Ahead of FDA Panel Vote on ALS Drug

    Advocacy groups are pressing U.S. federal regulators to fast-track approval of an experimental drug treatment for the deadly neurological disease ALS (amyotrophic lateral sclerosis), with a decision expected this week.

    The push to approve the drug, so far just called AMX0035, is based on partial data from cl...

    FDA Authorizes More E-Cigarette Products

    The U.S. Food and Drug Administration authorized several tobacco-flavored vaping products made by the company Logic on Thursday, and added that it would soon announce whether other big-name brands can continue to sell their products in this country.

    The agency said it has acted on approximately 99% of the nearly 6.7 million e-cigarette products submitted for authorization, including denia...

    FDA Says Gene-Edited Cattle Are Safe to Eat

    The U.S. Food and Drug Administration on Monday gave the green light to the sale of beef from gene-edited cattle.

    "Today's decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals," Dr. Steven M. Solomon, dir...

    Rodent Infestation Spurs Product Recall by Family Dollar Stores

    A wide range of human food, pet food, medical devices and drug products have been recalled by Family Dollar Inc. due to the risk of salmonella and other hazards associated with a rodent infestation at a company warehouse in Arkansas.

    The U.S. Food and Drug Administration-regulated products were shipped from the Family...

    FDA Warns of Rising Dangers of Unapproved Drug Tianeptine

    The U.S. Food and Drug Administration has issued another pointed warning about the dangers posed by tianeptine, an antidepressant that is not approved for any type of medical treatment in the United States.

    Topping the list of possible risks from ta...

    FDA Warns of Infant Formula Powders Tied to Infections

    Several powdered infant formula products have been recalled by Abbott Inc., following reports of four infants developing bacterial infections after consuming the products, the U.S. Food and Drug Administration said Thursday.

    "As this is a product used as the sole source of nutrition for many of our nation's newborns and infants, the FDA is deeply concerned about these reports of bacterial...

    U.S. Senate Narrowly Confirms Califf to Head FDA

    In a tight vote, the U.S. Senate on Tuesday confirmed Dr. Robert Califf to once again head the U.S. Food and Drug Administration, ending the agency's year-long stretch without a permanent leader.

    Six Republicans crossed over to support Califf in the Senate's 50-46 vote, while five Democrats opposed him. One senator voted present.

    Califf, a cardiologist and medical researcher, briefl...

    FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China

    A new lung cancer drug that has only been tested in China was soundly rejected by an advisory panel to the U.S. Food and Drug Administration on Thursday.

    Known as sintilimab, the treatment is a type of immunotherapy that unleashes the immune system to attack tumors. It was developed and tested in China by Innovent Biologics, which entered into an agreement with Eli Lilly that...

    CDC Backs Full Approval of Moderna COVID Vaccine

    The U.S. Centers for Disease Control and Prevention on Friday gave its full approval to Moderna's COVID-19 vaccine for use in people 18 and older.

    This follows a similar move made Jan. 31 by its sister agency, the U.S. Food and Drug Administration.

    The vaccine, which had before been available for that age group only under emergency use authorization (EUA), will be marketed as Spik...

    A Better Clot-Buster Drug When Strokes Attack?

    A newer type of "clot-busting" medication might be safer than the one long used for treating strokes, a preliminary study hints.

    Researchers found that among nearly 7,900 stroke sufferers, those treated with the drug -- called tenecteplase -- were less likely to suffer life-threatening brain bleeding as a side effect, compared to those given the standard medication alteplase.

    Overal...

    FDA Gives Moderna COVID Vaccine Full Approval

    Moderna's COVID-19 vaccine has received full approval for use in people 18 and older, the U.S. Food and Drug Administration announced Monday.

    The vaccine, which has been available for that age group under emergency use authorization (EUA), will be marketed as Spikevax. It's not yet fully approved or authorized for use in people younger than 18.

    This is the second COVID-19 vaccine to...

    FDA Limits Use of Two COVID Antibody Treatments

    MONDAY, Jan. 24, 2022 (healthDay News) -- The U.S. Food and Drug Administration is curtailing the use of two monoclonal antibody treatments that do not appear to work against the highly contagious Omicron variant.

    The combo treatments bamlanivimab/etesevimab and ...

    FDA May Limit Use of Two COVID Antibody Treatments

    MONDAY, Jan. 24, 2022 (healthDay News) -- The U.S. Food and Drug Administration may soon curtail the use of two monoclonal antibody treatments that do not appear to work against the highly contagious Omicron variant.

    The treatments made by Regeneron and Eli Lilly performed well against e...

    Ordering Groceries Online? Good Luck Finding Nutrition Info

    Online grocery shopping has skyrocketed during the pandemic, but many websites are making it hard to find nutrition information on products, a new study shows.

    In the United States, packaged foods are required to have a nutrition facts label, ingredients list and w...

    Amid U.S. Blood Shortage, New Pressure to Ease Donor Rules for Gay Men

    A three-month sexual abstinence rule for blood donations from sexually active gay and bisexual men should be dropped by the U.S. Food and Drug Administration, critics urge as the country struggles with a blood shortage.

    Right now, based on the slight chance of infection with HIV, men who have sex with men must abstain from sex with other men for 90 days before being eligible to donate blo...

    Senate Committee Backs Califf Nomination to Head FDA

    The nomination of former U.S. Food and Drug Administration head Dr. Robert Califf to again lead the agency now heads to the full Senate for a vote, after a Senate committee on Thursday voted 13-8 for approval.

    Among those who voted against Califf's nomination were Democrats who expressed concerns about his links to pharmaceutical companies, The New York Times reported.

    No d...

    Medicare Proposes to Only Cover Alzheimer's Drug Aduhelm for Use in Clinical Trials

    It's a move that could severely limit the number of people taking the controversial new Alzheimer's drug Aduhelm: Medicare on Tuesday proposed to only cover the cost of the pricey medication for people enrolled in approved clinical trials.

    A final decision on coverage is expected later this year.

    The drug costs $28,200 per year, but that cost will only be covered for participan...

    Do Not Use At-Home COVID Test Swabs in the Throat: FDA

    Swabs that come with at-home rapid antigen COVID-19 tests should be used in the nose and not the throat, the U.S. Food and Drug Administration warns.

    It issued the warning on Twitter in response to reports that some people are using swabs intended for nasal samples to take samples from their throats a...

    FDA Shortens Time to Booster After Moderna Vaccine to 5 Months

    Citing the rapid spread of the Omicron variant and the need for protection against it, U.S. federal health officials are shortening the recommended time between the second dose of the Moderna vaccine and a booster shot from six months down to five.

    "The country is in the middle of a wave of the highly contagious Omicron variant, which spreads more rapidly than the original SARS-CoV-2 vi...

    AHA News: Health Coach Was Once an Overworked, Unhealthy New Mom Who Had a Stroke at 32

    Kelly Fucheck woke up one summer Sunday ready to spend a quiet morning at home with her husband, Glen. Their toddler, Tomas, had spent the night at grandma's house.

    She picked out a pair of comfy pants, but when she tried to put them on, she swayed to the left. Then Kelly noticed a sharp pain in the back of her neck. She felt foggy.

    She went into the bathroom and splashed water on h...

    Aduhelm: Will Medicare Cover the Controversial Alzheimer's Drug?

    Following a months-long and unprecedented review, Medicare officials expect to announce within the next couple of weeks whether the program will cover the controversial Alzheimer's drug Aduhelm. The drug's benefits are in question and its annual price tag tops $28,000.

    The U.S. Centers for Medicare and Medicaid Services (CMS) tend to cover with little fanfare most drugs approved by its s...

    FDA May Allow Pfizer Boosters for 12- to 15-Year-Olds by Monday

    Younger adolescents may soon be eligible for COVID-19 booster vaccines, possibly by early next week.

    The U.S. Food and Drug Administration is planning on Monday to broaden booster eligibility to include 12- to 15-year-olds, sources told the New York Times. This would be for the Pfize...

    FDA Says Rapid At-Home COVID Tests Not as Sensitive to Omicron

    Early research suggests that some rapid COVID-19 tests may be less able to detect the Omicron variant, the U.S. Food and Drug Administration said Tuesday.

    To come to that conclusion, the agency used samples from patients confirmed to be infected with the Omicron variant to see how well the rapid antigen tests work.

    In a

  • Robin Foster
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  • December 29, 2021
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  • Flavored Vapes Still in Stores Despite Federal Ban

    Kid-friendly flavored e-cigarettes are still widely available online and in stores, despite a federal judge's ruling that should have pulled the products off store shelves by early September, a new report shows.

    The judge's ruling follows on U.S. Food and Drug Administration action that is nearly two years old.

    Citing risks to vulnerable children, the FDA first announced in January...