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The Latest Breaking News from FDA

Novavax Dive Continues As FDA Reviews New Covid Shot Information

Three days after the FDA's advisors recommended Novavax's Covid shot, the agency had yet to make a move, and NVAX stock toppled.

Investors Business Daily

Why Bluejay Diagnostics Shares Are Surging Higher Today

Shares of small-cap penny stock Bluejay Diagnostics, Inc. (NASDAQ: BJDX) are trading higher after the company announced that the FDA has agreed to consider its plan to pursue a De Novo submission for the Symphony IL-6 Test.

Benzinga

US ready to deliver millions of Covid vaccines to youngest children

Washington (AFP) - The White House on Thursday said it had an operational plan to deliver 10 million doses of Covid vaccine for the nation's youngest children by June 20, pending clearance by regulators.

AFP

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Misinformation clouds America’s most popular emergency contraception

A brand of specialty mozzarella cheeses. A collection of natural-gas storage terminals. And America’s top-selling emergency contraception.

Tribune News Service

TLSA: Clinical Improvements for 2nd SPMS Patient

By John Vandermosten, CFA NASDAQ:TLSA Clinical Results for Second SPMS Patient

Benzinga

Why Novavax Stock Is Falling Today

Novavax Inc (NASDAQ: NVAX) shares are trading lower Thursday following reports that the U.S. Food and Drug Administration's decision on the company's COVID-19 vaccine could be delayed to review manufacturing changes.

Benzinga

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

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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

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

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

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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:

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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

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…

The Street

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

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

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