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The Latest Breaking News from FDA

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

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.

WEKU

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

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

US clears updated Covid boosters targeting the newest Omicron strain

Omicron booster shots could become available within days

The Independent UK

FDA authorizes Omicron boosters

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

Axios

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

The Independent UK

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.

Roll Call

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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).

Benzinga

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.

Tribune News Service

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

The Independent UK

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.

Bangkok Post

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.

Benzinga

Should you get a Covid-19 booster now, or wait until the fall?

As we gear up for another wave of Covid-19 this fall, experts say you should definitely be prepared to get a booster shot. Here's when you should get it.

Inverse

Omicron booster shots are right around the corner

They're expected to become available right after Labor Day.

Axios

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Tribune News Service

Q&A: The new COVID vaccine booster is coming. Should you get it?

The COVID-19 vaccine is getting an upgrade.

StockNews.com

Should You Buy Eargo After the FDA Ruling on Hearing Aids?

Hearing aid maker Eargo (EAR) reported disappointing second-quarter results. And analysts seem bearish about the company’s growth prospects. However, EAR climbed considerably following the FDA approval for over-the-counter hearing aid sales. After gaining nearly 198% over the past month, is EAR still a buy now? Read more to find out….

WEKU

Coronavirus FAQ: Does a faint line on a self-test mean I'm barely contagious?

These days the world of at-home testing for COVID-19 is confusing. How often do I need to test to see if I'm really positive — or negative? Does a faint line mean I'm less contagious?

Benzinga

Two Entrepreneurs Launch CBD Supplements Marketplace, Emulating Planet Fitness' Strategy For Success

Two businessmen are launching what they aim to be the internet's one-stop marketplace for CBD supplements, striving to end the stigma of gummies, oils, and more with a welcoming site that touts many products.

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news in one place.

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Salon

Rural struggle for cancer medicine

One type of T-cell therapy is offered only at major transplant hospitals — meaning long drives for rural patients

Benzinga

Why Several Chinese Stocks Traded Higher; Here Are 58 Biggest Movers From Yesterday

Gainers Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) surged 95.3% to close at $0.2580 on Thursday after Ladenburg Thalmann initiated coverage on the stock with a Buy rating and announced a price target of $6.50.

Los Angeles Times

The FDA says you can get hearing aids without a prescription. Here's how

Despite what Mick Jagger claims, time is not on our side.

Los Angeles Times

COVID-19 test expired? Check this before you throw it out

Have your COVID-19 rapid tests expired? Don’t toss them yet.

Reason

New Survey Data Cast Further Doubt on the FDA's Opposition to Flavored E-Cigarettes

The "epidemic" of adolescent vaping seems to be fading fast, and vaping is replacing smoking among adults, a harm-reducing trend that regulators seem determined to discourage.

The Independent UK

Tweaked COVID boosters close but how much will they help?

COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but how much will they help

Benzinga

Why Snowflake Is Trading Higher By 20%, Here Are 51 Stocks Moving In Thursday's Mid-Day Session

Gainers Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) jumped 91% to $0.2530 after Ladenburg Thalmann initiated coverage on the stock with a Buy rating and announced a price target of $6.50.

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