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The Latest Breaking News from FDA

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

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

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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

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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

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

The Independent UK

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.

Roll Call

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

The Independent UK

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

Benzinga

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.

Bangkok Post

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

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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

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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?

Benzinga

Why Avalo Therapeutics Surged 32%; Here Are 111 Biggest Movers From Yesterday

Gainers AeroClean Technologies, Inc. (NASDAQ: AERC) gained 60.1% to settle at $7.27 on Tuesday after the company was granted US patent for an air treatment system and method.

Tribune News Service

Merck & Co.’s Januvia, a popular diabetes drug, was found to be contaminated with a potential carcinogen.

Los Angeles Times

As monkeypox cases spiral, US will stretch supply of vaccine by giving smaller doses

As monkeypox cases continue to increase among high-risk people, federal officials on Tuesday announced they will stretch limited vaccine supplies by giving just one-fifth the current dosage.

Al Jazeera

White House announces steps to boost monkeypox vaccine supply

The FDA has issued emergency authorisation for a dosage technique that would allow more shots of vaccine per vial.

Benzinga

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

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79 thousand shares, closed regular trading…

WEKU

With supplies low, FDA authorizes plan to stretch limited monkeypox vaccine doses

The Biden administration is allowing the shot to be given between layers of skin — a method that only requires a fifth of the full dose — in order to increase vaccinations and slow the outbreak.

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