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The Latest Breaking News from FDA

Breaking 3 publishers covering this story in the last 6 hours

1h ago Compounded Tirzepatide Vials From Cary, North Carolina Compounder Recalled Nationwide Over Sterility Doubts, With No Illnesses Reported
1h ago Salmonella Found in All Eight Oyster Samples From Virginia's Closed Little Wicomico River as Case Counts Diverge
2h ago ‘It’s a mess right now’: RFK’s sweeping changes place new vaccines in limbo
2h ago At-Home Skyrizi Induction Approved for Crohn's After 56% Reached Clinical Remission at 12 Weeks Versus 30% on Placebo
4h ago Awiqli Weekly Insulin Approved for Kids 10 and Up, but Child Data Come From One 18-Patient Dosing Study

FDA authorizes Omicron boosters

The updated shots are expected to become available after Labor Day.

Axios · Aug 31, 2022

US clears updated COVID boosters targeting newest variants

U.S. regulators have authorized updated COVID-19 boosters, the first to directly target today's most common omicron strain

The Independent UK · Aug 31, 2022

FDA greenlights new COVID-19 booster despite limited data - Roll Call

The Food and Drug Administration granted emergency authorization to Pfizer and Moderna for updated COVID-19 booster shots.

Roll Call · Aug 31, 2022

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EXCLUSIVE: Longeveron's Lomecel-B Product Gets US FDA Fast Track Designation For Treatment Of Hypoplastic Left Heart Syndrome in Infants

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Longeveron Inc (NASDAQ: LGVN) Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS).

Benzinga · Aug 31, 2022

FDA to approve new omicron COVID-19 boosters

The Food and Drug Administration is set to approve new boosters that specifically target the omicron mutation of COVID-19.

Tribune News Service · Aug 30, 2022

FDA chief says long-awaited opioid review still in the works

The head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway

The Independent UK · Aug 30, 2022

32 tonnes of impounded drugs to be destroyed

Thirty-two tonnes of seized illicit drugs will be incinerated at the Akkhie Prakarn Plc factory in Bang Pu Industrial Estate, Samut Prakan province, on Aug 30-31, Food and Drug Administration (FDA) secretary-general Paisal Dankhum said on Tuesday.

Bangkok Post · Aug 30, 2022

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Why Chimerix Is Trading Higher By Over 19%, Here Are 53 Stocks Moving In Monday's Mid-Day Session

Gainers Advanced Human Imaging Limited (NASDAQ: AHI) shares jumped 53% to $1.04. Advanced Human Imaging announced Sunday it signed a Master Services Agreement with Estonia-based Activate Health OÜ.

Benzinga · Aug 29, 2022

Should you get a Covid-19 booster now, or wait until the fall?

As we gear up for another wave of Covid-19 this fall, experts say you should definitely be prepared to get a booster shot. Here's when you should get it.

Inverse · Aug 29, 2022

Omicron booster shots are right around the corner

They're expected to become available right after Labor Day.

Axios · Aug 28, 2022

Q&A: The new COVID vaccine booster is coming. Should you get it?

The COVID-19 vaccine is getting an upgrade.

Tribune News Service · Aug 28, 2022

Should You Buy Eargo After the FDA Ruling on Hearing Aids?

Hearing aid maker Eargo (EAR) reported disappointing second-quarter results. And analysts seem bearish about the company’s growth prospects. However, EAR climbed considerably following the FDA approval for over-the-counter hearing aid sales. After gaining nearly 198% over the past month, is EAR still a buy now? Read more to find out….

StockNews.com · Aug 26, 2022

Coronavirus FAQ: Does a faint line on a self-test mean I'm barely contagious?

These days the world of at-home testing for COVID-19 is confusing. How often do I need to test to see if I'm really positive — or negative? Does a faint line mean I'm less contagious?

WEKU · Aug 26, 2022

Two Entrepreneurs Launch CBD Supplements Marketplace, Emulating Planet Fitness' Strategy For Success

Two businessmen are launching what they aim to be the internet's one-stop marketplace for CBD supplements, striving to end the stigma of gummies, oils, and more with a welcoming site that touts many products.

Benzinga · Aug 26, 2022

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Salon · Aug 26, 2022

Rural struggle for cancer medicine

One type of T-cell therapy is offered only at major transplant hospitals — meaning long drives for rural patients

Benzinga · Aug 26, 2022

Why Several Chinese Stocks Traded Higher; Here Are 58 Biggest Movers From Yesterday

Gainers Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) surged 95.3% to close at $0.2580 on Thursday after Ladenburg Thalmann initiated coverage on the stock with a Buy rating and announced a price target of $6.50.

Los Angeles Times · Aug 26, 2022

The FDA says you can get hearing aids without a prescription. Here's how

Despite what Mick Jagger claims, time is not on our side.

Los Angeles Times · Aug 26, 2022

COVID-19 test expired? Check this before you throw it out

Have your COVID-19 rapid tests expired? Don’t toss them yet.

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Reason · Aug 25, 2022

New Survey Data Cast Further Doubt on the FDA's Opposition to Flavored E-Cigarettes

The "epidemic" of adolescent vaping seems to be fading fast, and vaping is replacing smoking among adults, a harm-reducing trend that regulators seem determined to discourage.

The Independent UK · Aug 25, 2022

Tweaked COVID boosters close but how much will they help?

COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but how much will they help

Benzinga · Aug 25, 2022

Why Snowflake Is Trading Higher By 20%, Here Are 51 Stocks Moving In Thursday's Mid-Day Session

Gainers Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) jumped 91% to $0.2530 after Ladenburg Thalmann initiated coverage on the stock with a Buy rating and announced a price target of $6.50.

Benzinga · Aug 25, 2022

Vaping Companies Are Thumbing Their Noses At FDA Rules And Getting Away With It

The Food and Drug Administration is determined to crack down on businesses that sell vaping products without its approval since e-cigarettes and e-liquids that contain nicotine have been considered a prescription-only medicine since 2021, reported STAT.

Chicago Sun-Times · Aug 25, 2022

Congressman’s wife died after taking herbal remedy white mulberry leaf marketed for weight loss, diabetes

“Many people assume if that product is sold in the United States of America, somebody has inspected it, and it must be safe,” U.S. Sen. Dick Durbin, D-Ill., said when he introduced legislation to strengthen oversight of dietary supplements. “Unfortunately, that’s not always true.”

Salon · Aug 25, 2022

An "herbal remedy" results in death

Lori McClintock, the wife of U.S. Rep. Tom McClintock, died of "adverse effects of white mulberry leaf"

The Guardian - US · Aug 25, 2022

Death of congressman’s wife linked to ‘white mulberry leaf ingestion’ – coroner

Lori McClintock, wife of California Republican, had dehydration and gastroenteritis caused by leaf often used as health supplement

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