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The Latest Breaking News from FDA

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 · Jun 8, 2022

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

CNBC

Benzinga · Jun 8, 2022

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 · Jun 8, 2022

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

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 · Jun 8, 2022

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 · Jun 8, 2022

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 · Jun 8, 2022

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 · Jun 8, 2022

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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 · Jun 8, 2022

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 · Jun 7, 2022

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 · Jun 7, 2022

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

The U.S.

Benzinga · Jun 7, 2022

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.

WEKU · Jun 7, 2022

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.

Axios · Jun 7, 2022

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

The Independent UK · Jun 7, 2022

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Benzinga · Jun 7, 2022

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 · Jun 7, 2022

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 · Jun 7, 2022

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"…

Benzinga · Jun 7, 2022

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.

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Benzinga · Jun 7, 2022

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…

Benzinga · Jun 7, 2022

Merck, Ridgeback Announce New Molnupiravir Data From Late-Stage COVID-19 Study

Merck & Co Inc (NYSE:MRK) and Ridgeback Biotherapeutics announced that the Annals of Internal Medicine had published additional data from the Phase 3 MOVe-OUT trial of Lagevrio (molnupiravir) in non-hospitalized COVID-19 patients at high risk for progressing to severe disease. A lower proportion of molnupiravir-treated participants in the modified intent-to-treat population had an acute care…

Benzinga · Jun 7, 2022

Veru Seeks FDA Emergency Use Nod For Its COVID-19 Treatment

Veru Inc (NASDAQ:VERU) has submitted an emergency use authorization (EUA) for sabizabulin application to FDA for COVID-19 treatment. The application covers moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS). The EUA submission is based on the positive results from the Phase 3 COVID-19 clinical trial…

Reason · Jun 7, 2022

Drag Shows for Children Under Fire in Texas

Plus: Proud Boys indicted for seditious conspiracy, the FDA prepares to crack down on almond milk, and more...

Benzinga · Jun 7, 2022

The Daily Biotech Pulse: Veru Seeks Emergency Use Nod For COVID-19 Therapy, Vincerx Cuts Workforce, Moderna Starts Dosing In Flu Vaccine Study

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

Benzinga · Jun 7, 2022

95 Biggest Movers From Yesterday

Gainers AeroClean Technologies, Inc. (NASDAQ: AERC) shares gained 100.4% to close at $4.75 on Monday after the FDA granted clearance for the company's pūrgo technology, classifying it as a class II medical device.

Salon · Jun 6, 2022

Novavax's new shot may sway anti-vaxxers

Experts hope the new COVID vaccine, which uses older biotechnology, could help the unvaccinated come around

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