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The Latest Breaking News from FDA

The Daily Biotech Pulse: FDA Adcomm Backing For Novavax's COVID-19 Shot, New Data On Moderna's Omicron Vaccine, DBV Tech's Encouraging Peanut Allergy Trial Data

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

Benzinga

Psyched: Christie's Launches NFT Collection Supporting Psychedelic Science, Origin's Listing On CSE Gives Retail Investors Access To Private Companies

The world of psychedelics is getting a crossover with another category in the millennial catalog of trendy investments: NFTs.

Benzinga

Why Novavax Stock Is Trading Higher Today

Novavax Inc (NASDAQ: NVAX) shares are trading higher Wednesday after a committee of independent U.S. Food and Drug Administration (FDA) vaccine advisors voted to recommend Novavax's COVID-19 vaccine for Emergency Use Authorization (EUA).

Benzinga

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Morning Brief: Top Financial Stories Dominating on Wednesday, June 8

CNBC

Benzinga

What's Next For Novavax Stock As COVID Vaccine Clears Key Hurdle In US

After last week's scare stirred by the release of the Food And Drug Administration's briefing documents, Novavax (NASDAQ: NVAX) can now heave a sigh of relief.

Benzinga

DBV Technologies Shares Jump On Positive Data From Peanut Allergy Trial In Toddlers

DBV Technologies SA's (NASDAQ:DBVT) pivotal Phase 3 EPITOPE trial of Viaskin Peanut 250 µg for peanut-allergic toddlers ages 1 to 3 years met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect, with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, compared…

Benzinga

Novavax Stock Surges as FDA Panel Recommends EUA for Protein-Based Covid Vaccine

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based Covid vaccine," said CEO Stanley Erck.

The Street

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Stocks Lower, Novavax, WDC, Credit Suisse And The Denver Broncos - Five Things You Must Know

Stock futures lower as stagflation worries mount; Novavax surges as FDA panel recommends Covid vaccine; Western Digital leaps after board agrees to consider flash memory sale; Credit Suisse slumps after third straight profit warning and Denver Broncos sold to Walmart heir for record $4.65 billion

The Street

20 Stocks Moving in Wednesday's Pre-Market Session

Gainers Cyren Ltd. (NASDAQ: CYRN) rose 31.1% to $2.32 in pre-market trading after the company entered into an agreement with Content Services Group to sell all equity interests in its legacy secure email gateway business.

Benzinga

79 Biggest Movers From Yesterday

Gainers AeroClean Technologies, Inc. (NASDAQ: AERC) gained 154.7% to settle at $12.10 on Tuesday on continued strength after the FDA granted clearance for the company's pūrgo technology, classifying it as a class II medical device.

Benzinga

Novavax COVID-19 shot gets backing from FDA advisory panel

WASHINGTON — Novavax Inc.’s coronavirus vaccine won the support of a panel of U.S. government advisers, paving the way for authorization of another tool to fight the coronavirus.

Tribune News Service

Seeing through the haze: The new pot law

In a highly anticipated move, Thailand is set to decriminalise cannabis and hemp on June 9 as a new law takes effect. The milestone makes Thailand the first Asian nation to decree home cultivation legal, but there are still prohibitions. The Bangkok Post breaks down pressing questions surrounding the new…

Bangkok Post

American parents struggle to feed their babies, and market failure is to blame

There are a few reasons for the dire shortage of baby formula in the US. One is that just four producers control more than 90% of the market.

Crikey

Novavax's COVID-19 Vaccine For Adults Over 18 Backed By FDA Advisors: What's Next?

Novavax, Inc. (NASDAQ: NVAX) announced the U.S.

Benzinga

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Benzinga

Novavax Shares Gain Following FDA Advisory Committee's Positive Vote On Emergency Use Authorization (EUA) For COVID-19 Vaccine

Novavax’s (NASDAQ: NVAX) COVID-19 vaccine (NVX-CoV2373) receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC), recommending FDA to grant Emergency Use Authorization (EUA) for individuals aged 18 years and over.

Benzinga

U.S. FDA Approves Regeneron And Sanofi's Lead Drug For Skin Inflammation In Children

The U.S.

WEKU

Advisers to the FDA back Novavax COVID vaccine

Advisers to the Food and Drug Administration overwhelmingly voted to recommend that it authorize Novavax's two-dose vaccine against COVID-19.

Axios

FDA advisers recommend Novavax COVID shot in adults

Officials said Novavax could fill an unmet need because there aren't non-mRNA COVID vaccines that can serve as first line defenses.

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news in one place.

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The Independent UK

FDA advisers back Novavax COVID-19 shots as new US option

A more traditional kind of COVID-19 vaccine has moved a step closer to the U.S. market

Benzinga

What's Going On With Novavax Stock Today?

Novavax Inc (NASDAQ: NVAX) shares have been halted since the pre-market session as the U.S. Food and Drug Administration holds a meeting to determine the fate of the company's COVID-19 vaccine.

Benzinga

Revive Therapeutics Moves On Step Closer In COVID Trial By Submitting Data Access Plan To The FDA

It was an expected step, but a notable one nonetheless. Revive Therapeutics Ltd.(OTC: RVVTF) revealed they have submitted their Data Access Plan to the U.S. Food & Drug Administration (FDA).

Benzinga

FDA Sounds Positive On Bluebird's One Gene Therapy But Doubts Another

The FDA signaled in briefing documents released that it may approve Bluebird bio Inc's (NASDAQ:BLUE) beti-cel gene therapy to treat β-thalassemia for those who require regular blood transfusions. The Prescription Drug User Fee Act (PDUFA) goal dates for beti-cel and eli-cel are August 19 and September 16. Bluebird bio's blood disorder treatment demonstrates "clinically meaningful"…

Investors Business Daily

Novavax Stock Jumps After FDA Advisors Endorse Its Covid Shot

An FDA panel voted nearly unanimously in favor of Novavax's Covid shot on Tuesday. After yo-yoing Wednesday, NVAX stock settled up.

Benzinga

38 Stocks Moving In Tuesday's Mid-Day Session

Gainers Kiromic BioPharma, Inc. (NASDAQ: KRBP) gained 70% to $0.4900 after the company entered a sponsored research agreement under which in vivo preclinical data will be generated from Kiromic's Gamma Delta T cell allogeneic therapies.

Benzinga

In Eli Lilly's Lebrikizumab Atopic Dermatitis Study, Majority Of Patients Maintained Skin Clearance At One Year

Eli Lilly And Co (NYSE:LLY) announced topline results from one-year analyses of the efficacy and safety of lebrikizumab for moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 trials (ADvocate 1 and 2) showed that 8/10 of patients who achieved clinical response with lebrikizumab monotherapy at 16 weeks maintained skin clearance…

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