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The Latest Breaking News from FDA

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

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ:BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients. BioMarin shares traded as high as 2.28 percent, in a range of $91.39 to $93.68…

Benzinga

US House panel slams Trump’s COVID response; report mentions early role from Mehmet Oz

Mehmet Oz’s advocacy for the drug hydroxychloroquine in the early days of the COVID-19 pandemic is cited in a new congressional report that accuses former President Donald Trump’s administration of pressuring the Food and Drug Administration to endorse unproven treatments and vaccines.

The Philadelphia Inquirer

Study: Pfizer COVID pill showed no benefit in younger adults

Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults

The Independent UK

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Eleventh Circuit Finds FDA Treatment of Vaping Product Marketing Applications to be Arbitrary & Capricious

The likelihood that the Supreme Court considers the FDA's treatment of vaping products is increasing.

Reason

Trump officials tried to ‘bully’ FDA over Covid treatments, House panel says

Congressional investigation finds new evidence of efforts to override health decisions early in pandemic

The Guardian - US

Taking Care Of Cannabis Consumers, Federal Trade Commission Issues Refunds To CBD Buyers, Here's Why

Recently, the Federal Trade Commission (FTC) announced that it will send payments to 576 consumers across the country who purchased 'deceptively marketed' cannabidiol (CBD) products from Arizona-based Kushly Industries LLC.

Benzinga

Senate Candidate Dr. Oz, Who Once Sang Pot's Praises, Now Thinks Supporting Legalization Is Clearly Crazy

The former TV doctor, who two years ago said "we ought to completely change our policy on marijuana," mocks his opponent for agreeing.

Reason

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How common is Paxlovid rebound as Jill Biden tests positive again for Covid?

Paxlovid good at stopping hospitalisation for high-risk groups, despite occasional rebound

The Independent UK

Panel details pressure campaign for unproven COVID treatment

A special House panel looking into the government's coronavirus response says the Trump White House tried to pressure U.S. health experts into reauthorizing the anti-malaria drug hydroxychloroquine that had been discredited as a COVID-19 treatment

The Independent UK

A Cop Rear-Ended a Car, Sending a Toddler to the Hospital. The Car's Driver Was Breathalyzed. The Cop Wasn't.

Plus: Twitter whistleblower reports, court says FDA must reconsider vaping products, and more...

Reason

More communities are giving flavored tobacco the boot. Will California follow?

SAN JOSE, Calif. — California’s third-largest city banished flavored tobacco products from store shelves this summer, joining scores of other cities and counties in the state in a public health push to reduce nicotine addiction among youths and young adults.

Tribune News Service

Advocates urge FDA action to ease policing fears in menthol ban

WASHINGTON — Experts and advocates are calling on the Biden administration to do more to avoid potential confrontations between police and racial minorities if the Food and Drug Administration finalizes a ban on menthol cigarettes.

Tribune News Service

Depression ruined her life for years. Then doctor’s ‘helmet’ changed everything

KANSAS CITY, Mo. -- Depression sucked the life from Lori Jackson’s time on this earth for nearly 40 years. On her darkest days in college she hung a blanket over her dorm room window to block out the light and slept, skipping classes.

Tribune News Service

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

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The Conversation

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.

Fortune

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.

Benzinga

BLRX: September NDA

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

Roll Call

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.

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news in one place.

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Benzinga

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.

WEKU

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.

Benzinga

NHWK: Scorpion Grand Opening 3Q:22

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

Los Angeles Times

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.

The Independent UK

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

Bangkok Post

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.

The Independent UK

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

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