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The Latest Breaking News from FDA

Eledon Pharmaceuticals' Stock Gains As FDA Grants Orphan Drug Designation

Eledon Pharmaceuticals (NASDAQ: ELDN) received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Tegoprubart for the Prevention of Allograft Rejection in Pancreatic Islet Cell Transplantation.

Benzinga

Kansas man says he got lung cancer from CPAP sleep apnea machine. He’s suing

KANSAS CITY, Mo. — A Johnson County, Kansas, man blames his sleep apnea machine for giving him lung cancer and is suing the manufacturer, which last year recalled the machine and several other breathing-aid devices.

Tribune News Service

US Schedules Covid-19 Vaccines For Children Below Five Years

The U.S. government is preparing to launch vaccines for children below five in conjunction with educational and outreach efforts, pending approval by federal regulators, the Wall Street Journal reports. The government looks to provide ten million initial doses as the virus spreads nationwide, leaving the parents anxious. The vaccinations could begin…

Benzinga

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Officials: Millions of COVID-19 shots ordered for youngest

White House officials say orders have been coming in for COVID-19 vaccine doses for small children

The Independent UK

Over 100,000 people register to grow cannabis

More than 100,000 people registered to cultivate cannabis via the application and website of the Food and Drug Administration on Thursday morning as the legalisation of cannabis and hemp took effect.

Bangkok Post

New vaccine may be option for troops with religious concerns

A COVID-19 vaccine that could soon win federal approval may offer a boost for the U.S. military: an opportunity to get shots into some of the thousands of service members who have refused the other coronavirus vaccines for religious reasons

The Independent UK

Vertex Pharma Gains FDA Breakthrough Therapy Designation For Kidney Disease Drug

Vertex Pharmaceuticals (NASDAQ: VRTX) received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate inaxaplin (VX-147) for the treatment of patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS).

Benzinga

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BioCryst Gets FDA Fast Track Designation For Bone Formation Disorder Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BioCryst Pharmaceuticals's (NASDAQ: BCRX) lead drug candidate BCX9250 for the prevention of heterotopic ossification (HO) in patients with fibrodysplasia ossificans progressiva (FOP).

Benzinga

Why Alpha Tau Medical Shares Are Rising Today

Alpha Tau Medical Ltd. (NASDAQ: DRTS) shares are trading higher after the company announced FDA approval of its IDE application to initiate its multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT.

Benzinga

Why Aldeyra Therapeutics' Shares Are Soaring Today?

Aldeyra Therapeutics Inc's (NASDAQ:ALDX) Phase 3 TRANQUILITY-2 trial of reproxalap for dry eye disease has achieved the primary endpoint. Reproxalap was statistically superior to the vehicle for each of the two prespecified primary endpoints, Schirmer test and ≥10 mm Schirmer test responder proportions after a single day of dosing. The Schirmer test,…

Benzinga

Why Stealth BioTherapeutics Shares Are Surging Today?

Stealth BioTherapeutics Corp (NASDAQ:MITO) presented new SBT-272 preclinical data demonstrating functional improvement in upper motor neurons with TDP-43 pathology. TDP-43 pathology plays a significant role in amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The data were presented at the Keystone Neurodegeneration Symposium. A Phase 1 study to evaluate the safety and tolerability…

Benzinga

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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Benzinga

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

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.

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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.

Tribune News Service

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.

Bangkok Post

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…

Benzinga

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

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.

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