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The Latest Breaking News from FDA

Recap Of Tuesday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE:MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). Merck shares traded in a range of $89.72 to $90.97 on day volume of 5.2…

Benzinga

Over-the-counter hearing aids have been greenlighted by the FDA – your local pharmacist will soon be able to sell you the device you need

After a long delay, the Food and Drug Administration issued final regulations Aug. 16, 2022, for over-the-counter hearing aids. The final rule is effective 60 days from its publication, meaning that consumers could see OTC hearing aids hitting the shelves of community pharmacies nationwide by October 2022.

The Conversation

Will the new over-the-counter hearing aids work for you? Experts weigh in

The FDA approved over-the-counter hearing aids, which will be available for those with “mild to moderate” hearing loss. These experts delve into what you should know.

Fortune

From analysis to the latest developments in health,
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BLRX: September NDA

By John Vandermosten, CFA NASDAQ:BLRX READ THE FULL BLRX RESEARCH REPORT

Benzinga

Advocates urge FDA action to ease policing fears in menthol ban - Roll Call

An estimated 85 percent of Black smokers use menthols, according to the FDA, compared with 30 percent of white smokers.

Roll Call

Why Amazon Shares Traded Lower; Here Are 74 Biggest Movers From Yesterday

Gainers Bright Minds Biosciences Inc. (NASDAQ: DRUG) shares jumped 72.8% to close at $2.16 on Monday as the stock continued to see momentum despite the company last week announcing it is not aware of any developments that would explain the recent surge.

Benzinga

Pfizer asks FDA to greenlight new omicron booster shots, which could arrive this fall

Pfizer has submitted data on its bivalent COVID-19 booster shot that specifically targets the latest omicron subvariants. If authorized, the company says the shots could be ready as soon as September.

WEKU

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Why Pharvaris Stock Crashed — And Why At Least One Analyst Isn't Worried

Biotech stock Pharvaris plummeted Monday after the Food and Drug Administration placed a pair of its clinical studies on hold.

Investors Business Daily

NHWK: Scorpion Grand Opening 3Q:22

By John Vandermosten, CFA NYSE:NHWK READ THE FULL NHWK RESEARCH REPORT

Benzinga

Food poisoning and unsafe temperatures: Many meal kit companies aren't FDA regulated

LOS ANGELES — Days after trying a new lentil product from the meal subscription company Daily Harvest, Los Angeles resident Jackie Sloboda was debilitated by full-body itching, stabbing abdominal pains and jaundice that turned her skin and eyes yellow.

Los Angeles Times

What to know about eating raw oysters safely after two reported deaths from shellfish

Oysters that contain Vibrio do not ‘look, smell, or even taste different from any other oyster,’ CDC states

The Independent UK

Covid medication to be available at pharmacies soon

The Food and Drug Administration (FDA) has drafted an announcement that will allow pharmacies to fill prescriptions for Covid-19 medication, in line with a decision by the Centre for Covid-19 Situation Administration.

Bangkok Post

This Unpopular Move Could Save Invitae

Offloading a recent acquisition could accelerate the path to profitability – or an acquisition.

The Street

What to know about eating oysters safely after two reported deaths from shellfish

Oysters that contain Vibrio do not ‘look, smell, or even taste different from any other oyster,’ CDC states

The Independent UK

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Chicago Sun-Times

Hearing aids OK’d for over-the-counter sale starting in October, prices expected to fall

The Food and Drug Administration said the new regulation creates a new class of hearing aids that don’t require a medical exam or prescription. They’ll be sold online or over-the-counter at pharmacies and other stores.

Bangkok Post

Covid vaccine plan for the very young

The government plans to buy 2.9 million doses of Covid-19 vaccine from Pfizer for children aged from six months to four years.

Benzinga

This Biotechnology Stock Tumbled 37%; Here Are 70 Biggest Movers From Yesterday

Gainers Bright Minds Biosciences Inc. (NASDAQ: DRUG) shares climbed 135.9% to close at $2.17 on Thursday.

WEKU

What's behind the FDA's controversial strategy for evaluating new COVID boosters

Some scientists are alarmed that the agency plans to evaluate the next generation of boosters by reviewing mouse studies alone. Others say there's no time to waste waiting for human trials.

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The Philadelphia Inquirer

Hearing aids will now be available without a hearing test. Here’s what to know about the new rule

Adults with mild to moderate hearing loss will now be able to buy hearing aids without getting their hearing tested by an audiologist or other specialist, under a new FDA rule announced Tuesday.

Benzinga

'Stoner Patch' Or 'Sour Patch Kids'? Hard To Tell, British Police Launched A Raid To Find Out

The Police in the UK recently seized almost 150 separate items, including cannabis edibles, marijuana resin, more than 5kg of cannabis flowers, and nearly £5,000 in cash.

Benzinga

If You Invested $1,000 In Johnson & Johnson Stock At Its COVID-19 Pandemic Low, Here's How Much You'd Have Now

Investors who bought stocks during the COVID-19 market crash in 2020 have generally experienced some big gains in the past two years. But there is no question some big-name stocks performed better than others since the pandemic bottom.

Benzinga

Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ:BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Bluebird shares traded in a range of $6.13 to $8.18 on a day…

Reason

What We Know About the FBI's Latest National 'Human Trafficking' Sting

Plus: Book ban enthusiasm ensnares Bible, free speech for nutrition advice, and more...

Benzinga

NOVN: EPI Revenue Trends Are Strong

By John Vandermosten, CFA NASDAQ:NOVN READ THE FULL NOVN RESEARCH REPORT

Reason

Arizona Expands the Right To Try New Medical Treatments

It’s a small step toward breaking down barriers between patients and innovative medicine.

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