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The Latest Breaking News from FDA

CDC advisers endorse booster shots that target omicron for Americans 12 and up

The United States should replace most of its COVID-19 booster shots with updated versions that target the dominant omicron strains, an influential group of vaccine experts that advises the Centers for Disease Control and Prevention said Thursday.

Los Angeles Times

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

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ:NTLA) lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in a range of $56.52 to $60.06 on day volume of 901.43 thousand shares, closed regular trading session at $59.97. The company…

Benzinga

CDC recommends new booster shots to fight omicron

CDC Director Rochelle Walensky has signed off on updated versions of the Moderna and Pfizer-BioNTech vaccines that target the original virus and the omicron subvariants.

WEKU

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read the most diverse news in one place.

5 Dividend Stocks to Buy and Hold Forever

Persistent economic turbulence and an uncertain outlook have led investors to prioritize steady income generation from their investments. Hence, fundamentally sound dividend yielders with a solid track record and potential for perpetual growth Merck (MRK), Abbott (ABT), Cigna (CI), Energy Transfer (ET), and Kronos (KRO) could be permanent additions to…

StockNews.com

Want to Lower Your Risk? Give These 3 Safe Stocks a Try

The uncertainty surrounding the market and the economy because the Federal Reserve signaled to continue hiking interest rates is making investors seek low-risk investments. Given lower volatility and attractive dividend payments, Johnson & Johnson (JNJ), CVS Health (CVS), and Summit Financial Group (SMMF) could be good candidates to consider on…

StockNews.com

Magic Mushrooms Producer Optimi Keeps Betting On The FDA-approval Of Psychedelics

Optimi Health (OTCQX: OPTHF) has released an operational update on its planned year of commercialization, including the launch of psychedelics catalog.

Benzinga

CDC advisers weigh who needs updated COVID booster and when

Government advisers are debating who should should get new updated COVID-19 boosters and when

The Independent UK

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Will omicron-specific booster shots be more effective at combating COVID-19? 5 questions answered

On Sept. 1, 2022, the Centers for Disease Control and Prevention endorsed the use of updated COVID-19 booster shots that are specifically tailored to combat the two most prevalent omicron subvariants, BA.4 and BA.5. The decision comes just a day after the Food and Drug Administration’s emergency use authorization of…

The Conversation

Top Financial Stories Thursday, September 1: Netflix Weighs Charging High Sum For Ads, Self Harm posts Grow On Twitter, California Fast-Food Bill Faces Industry Backlash…

Wall Street Journal

Benzinga

Michael Hiltzik: In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments

A federal judge in Riverside, California, declared a stem cell treatment firm operating in the state to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous.

Los Angeles Times

New COVID-19 booster shots could be available in Chicago after Labor Day

The FDA today authorized the new booster, which could arrive as early as next week in Chicago, where nearly 2 million residents are expected to be eligible.

Chicago Sun-Times

FDA Approves Updated COVID-19 Booster Shots

But does everyone really need to get boosted?

Reason

What are the side effects of the new Covid-19 bivalent booster?

Last week, the FDA authorized both Pfizer and Moderna's Omicron-specific jabs. Experts say to get them as soon as they are available to you.

Inverse

Bluebird bio Seeks Back-to-Back Nods, 'Go' or 'No-Go' For Revance's Botox Rival, Amylyx' Twin Hurdles And More: September's Key PDUFA Catalysts Biotech Investors Must Know

After August’s mixed tally for Food and Drug Administration approvals, investors turn to a new month, which has a fairly loaded calendar.

Benzinga

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WEKU

FDA authorizes first revamp of COVID vaccines to target omicron

The new shots from Moderna and Pfizer-BioNTech target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now.

Benzinga

MingMed Biotech Joins Queue of Revenue-less Drug Startups Seeking IPO Cash

Key Takeaways: With no drug revenues and growing R&D costs, MingMed Biotechnology plans to feed its cash-burning machine with a Hong Kong IPO Company has seven drugs in development, including six in the clinical stages By Ellie Si

The Independent UK

US clears updated Covid boosters targeting the newest Omicron strain

Omicron booster shots could become available within days

Axios

FDA authorizes Omicron boosters

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

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The Independent UK

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

Roll Call

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.

Benzinga

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).

Tribune News Service

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.

The Independent UK

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

Bangkok Post

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.

Benzinga

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.

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