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The Latest Breaking News from FDA

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

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

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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

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

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

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

The U.S.

Benzinga

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

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

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

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"…

Benzinga

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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…

Benzinga

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

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…

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Reason

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

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

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

Novavax's new shot may sway anti-vaxxers

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

Bangkok Post

US move affects Africa's vax drive

The US Food and Drug Administration's recent decision to limit the use of the Johnson & Johnson Covid-19 vaccine to adults who cannot or will not get another vaccine will have profound consequences for African countries. The FDA said its move reflected the risk that the vaccine might cause a…

Benzinga

Needham Says Merus' ASCO Update On Zeno 'Positive'

Needham writes that Merus NV (NASDAQ: MRUS) has enough data to initiate an FDA marketing application filing in mid-2022 after presenting Zenocutuzumab (Zeno) data in NRG1-fusion (NRG1+) Cancer.

Benzinga

SVB Leerink Sees Over 600% Upside For This Penny Biotech Stock

SVB Leerink initiated Selecta Biosciences Inc (NASDAQ:SELB) coverage with an Outperform rating and a price target of $7. The analysts view ImmTOR's approach to mitigate ADAs as de-risked by early clinical data from SEL-212 and believe that the ability to tame the immune response bodes well for ImmTOR's clinical potential in combination with…

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