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The Latest Breaking News from FDA

Coming soon: Over-the-counter hearing aids

People with hearing loss will soon be able to buy hearing aids without needing to have an exam, prescription or special fitting first.

Axios

Over-the-counter hearing aids expected this fall in US

U.S. regulators have finalized a long-awaited rule that's expected to allow millions of Americans to buy hearing aids without a prescription

The Independent UK

FDA finalizes over-the-counter hearing aid rule - Roll Call

The FDA finalized a long-awaited rule allowing people with mild to moderate hearing loss to buy a hearing aid without first seeing a doctor.

Roll Call

From analysis to the latest developments in health,
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The U.K. approved omicron-specific booster shots. They're coming to the U.S. soon

In the U.S., officials have asked vaccine makers to target BA.5, rather than the original omicron strain. That has delayed the boosters' development — but officials hope they will be more effective.

WEKU

Government plan to cut civil servants’ redundancy pay ‘add insult to injury’, says union

Ministers want ‘job cuts on the cheap’, says PCS union – as Rishi Sunak attacks ‘bloated’ state

The Independent UK

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

Gritstone bio (NASDAQ:GRTS) announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The initial results from the study are expected during second half of 2023. Gritstone shares traded in a range of $3.96 to $4.24…

Benzinga

Sunak commits to Civil Service cuts as part of plan for Whitehall ‘shake-up’

The former chancellor said the ‘bloated post-Covid state is in need of a shake-up’.

The Independent UK

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No Häagen-Dazs recall in Thailand - FDA

Certain batches of Häagen-Dazs ice cream products that have been found to be contaminated with traces of a chemical linked to cancer have not been imported into Thailand, Food and Drug Administration (FDA) deputy secretary-general Weerachai Nolwachai said on Saturday.

Bangkok Post

Smaller doses of monkeypox vaccine got the OK. Here's how that works at one clinic

LOS ANGELES — Mark Webber and Doug Brown rose before dawn to make the trip from Agoura Hills, California, arriving around 6 a.m. at the Leimert Park clinic in the hopes of getting vaccinated against monkeypox.

Los Angeles Times

Coronavirus FAQ: I'm confused by the new testing advice! Do it once, twice ... thrice?

The FDA issued revised guidance about how often to test after exposure to someone with COVID or after symptoms occur. It's not exactly the same as what the CDC says. What's the best way to proceed?

WEKU

Can Medicare negotiate the price of prescription drugs?

The ten most expensive drugs covered by Medicare are responsible for about a fifth of total Medicare drug spending.

USAFacts

Most of nation 'will get Covid by year's end'

It should take about three years from the emergence of Covid-19 for it to infect most of Thailand's population, a virologist said on Thursday citing past surveillance of the coronavirus.

Bangkok Post

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

The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ:RDUS), New Drug Application (NDA) for elacestrant for patients with ER+/HER2- advanced or metastatic breast cancer. The agency has granted Priority Review designation and assigned a target action date of February 17, 2023. Radius Health…

Benzinga

The FDA recommends 3 home tests if you're exposed to COVID to boost accuracy

Previously, the FDA had advised taking two rapid antigen tests over two or three days to rule out infection. But the agency says new studies suggest that protocol can miss too many infections.

WEKU

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The Independent UK

FDA: Take 3 home tests if exposed to COVID to boost accuracy

New U.S. recommendations call for three home tests for people exposed to COVID-19 to improve accuracy

Roll Call

Citing lower risk, CDC changes COVID-19 exposure guidelines - Roll Call

Even as hospitalizations tick upward, CDC releases eased measures aimed at reducing pandemic-era barriers to everyday activity.

The Independent UK

Monkeypox vaccine maker warns Biden administration against strategy to stretch supply

Plan to multiply 440,000 doses into 2 million is ‘safe and effective’ and will go ahead says HHS secretary

Benzinga

Benzinga Before The Bell: iPhone 14 Might Be Costlier, Coinbase Face Another SEC Probe, Binance Sees Crypto User Growth And Other Top Financial Stories Thursday, August 11

Reuters Binance Says Worldwide Inflation Is Driving Crypto User Growth

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news in one place.

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Bangkok Post

Fake test kits, medical products seized

Fake Covid-19 antigen test kits and other medical gear, worth about 2 million baht, were seized during police-led raids in Nakhon Pathom and Nonthaburi provinces on Thursday.

Benzinga

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

Bristol Myers Squibb (NYSE:BMY) and 2seventy bio (NASDAQ:TSVT) announced positive topline results from KarMMa-3, a Phase 3 study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory. Bristol Myers shares traded in a range of $73.95 to $75.32 on a day volume…

Benzinga

Biotech Daily: Cancer Causing Impurities In Merck's Diabetic Drug, Vir Bio-GSK Shun FDA Submission Plans For COVID-19 Treatment, Aethlon's Monkeypox Trial

Here's a roundup of top developments in the biotech space over the last 24 hours:

Los Angeles Times

This drug could help treat monkeypox. Some patients have struggled to get it

Joseph Cassara decided to head back to the emergency room when the pain made it unbearable to swallow.

Benzinga

Benzinga Before The Bell: Elon Musk Sells $6.8B Tesla Shares, Nio Begins ES7 Test Drives, Coinbase Accused Of Misleading Investors And Other Top Financial Stories Wednesday, August 10

Wall Street Journal

Benzinga

ECOR: Consistent Expansion of Distribution

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

The Philadelphia Inquirer

How to tell if your COVID test is expired

Did you stock up on rapid at-home COVID-19 tests only to realize they all expire much sooner than you expected?

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