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The Latest Breaking News from FDA

46 Stocks Moving In Monday's Mid-Day Session

Benzinga

NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC

NeuroSense Therapeutics Ltd (NASDAQ:NRSN) has received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects. PrimeC is a novel extended-release oral formulation composed of a fixed-dose combination of ciprofloxacin and celecoxib. PrimeC targets several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration,…

Benzinga

Certain type of Jergens moisturiser voluntarily recalled over possible bacteria contamination, FDA says

Recall applies to certain sizes of Jergens Ultra Healing Moisturiser

The Independent UK

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Walmart and Kroger pancake mix recalled over ‘cable fragments’

Those who think they may have purchased two kinds of pancake and waffle mix are being asked to immediately throw them away

The Independent UK

Conforme las píldoras abortivas aumentan, algunos estados se mueven para frenarlas

En junio, se espera que el Tribunal Supremo de Estados Unidos mitigue o derribe la decisión —Roe v. Wade— de casi 50 años de antigüedad que tiene sobre el derecho al aborto, dándole a los estados un amplio margen para restringir el procedimiento.

Tribune News Service

Here's Why Marinus Pharmaceuticals Shares Are Moving

Marinus Pharmaceuticals Inc (NASDAQ: MRNS) shares are trading higher by 25.0% at $10.72 after the company announced the FDA has approved ZTALMY oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder.

Benzinga

HC Wainwright Sees Almost 1000% Upside On Spectrum Pharma Stock

HC Wainwright reiterates the Buy rating on Spectrum Pharmaceuticals Inc (NASDAQ:SPPI), with a price target of $10. The analyst projects revenues of $170 million for Rolontis and $328 million for poziotinib in 2026. Eflapegrastim (formerly known as Rolontis; to be renamed) is a long-acting granulocyte colony-stimulating factor intended to stimulate neutrophil production for chemotherapy-induced neutropenia…

Benzinga

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Sorrento's Pain Company Reveals Final Results For SP-102 Data For Sciatica Pain Management

Sorrento Therapeutics Inc's (NASDAQ: SRNE) subsidiary Scilex Holding Company has announced final results from its SP-102 Phase 3 Pivotal Trial C.L.E.A.R. Program. SP-102 (Semdexa) has received Fast Track status from the FDA.

Benzinga

Kiora Pharma Snags Orphan Drug Tag For Inherited Genetic Eye Disease Candidate

The FDA has granted Orphan Drug designation to Kiora Pharmaceuticals Inc's (NASDAQ:KPRX) KIO-301 for Retinitis Pigmentosa. Retinitis Pigmentosa is an inherited genetic eye disease that can lead to severe vision loss due to rods and cones degeneration. Kiora expects to initiate clinical trials of KIO-301 in Q3 2022. The Company plans to begin a…

Benzinga

BTAI: Final Countdown to April 5, 2022 PDUFA Date for BXCL501…

By David Bautz, PhD NASDAQ:BTAI READ THE FULL BTAI RESEARCH REPORT

Benzinga

Zosano Lays Off ~30% Of Its Workforce After FDA Rejection Of Migraine Drug Application

Zosano Pharma Corp (NASDAQ: ZSAN) is looking at strategic alternatives and

Benzinga

World Sleep Day: What an expert says about using melatonin to sleep

Melatonin is an over-the-counter sleep aid that’s loosely regulated by the FDA

The Independent UK

Lexicon Announces Loan Facility Of $150M With Oxford Finance To Support Sotagliflozin Commercialization

Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) entered into a loan facility with Oxford Finance LLC for $150 million to support commercial preparations and the potential launch of sotagliflozin in heart failure. The loan facility consists of four tranches, each maturing in March 2027. An initial $25 million tranche was funded at closing. The second $25 million tranche…

Benzinga

B70m in fake cosmetic products seized

Police have seized about 70 million baht worth of fake cosmetic products bearing the names of 18 brands during a raid on a house in Bangkok’s Suan Luang district.

Bangkok Post

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Benzinga

Like Pfizer, Moderna Seeks FDA Approval For Fourth COVID-19 Shot Or Second Booster Dose

Moderna Inc (NASDAQ: MRNA) has asked the FDA to authorize a

Asharq Al-Awsat

Moderna Seeks US Approval of Second Covid Booster

Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults. The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18…

The Guardian - US

Carcinogenic chemical benzene found in hundreds of US personal care products

Independent lab found the chemical in more than a quarter of items it tested – sometimes at levels considered ‘life threatening’

Axios

Moderna asks FDA to authorize additional booster shot for all adults

The request is much broader than Pfizer's, which sought to authorize a second booster for people over 65.

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Benzinga

OPNT: Data from OPNT003 Pharmacodynamic Trial in 2Q22…

By David Bautz, PhD NASDAQ:OPNT READ THE FULL OPNT RESEARCH REPORT

Benzinga

BLRX: 2021 Results

By John Vandermosten, CFA NASDAQ:BLRX READ THE FULL BLRX RESEARCH REPORT

Benzinga

RVPH: 2021 Results

By John Vandermosten, CFA NASDAQ:RVPH READ THE FULL RVPH RESEARCH REPORT

Benzinga

Why Are TC Biopharm Shares Trading Higher Today

The FDA has granted Orphan Drug designation to TC Biopharm Ltd's (NASDAQ:TCBP) lead product OmnImmune for use in Acute Myeloid Leukemia. After reviewing the Phase 1b/2a trial results in relapsed/refractory AML patients, the FDA approved the Company's application for Orphan Drug Status. "We look forward to the advancement of OmnImmune® in the Phase 2b/3…

Benzinga

Aquestive's AQST-109 Receives Fast Track Tag For Allergic Reactions

The FDA has granted Fast Track Designation to Aquestive Therapeutics Inc's (NASDAQ: AQST) AQST-109 for allergic reactions. AQST-109 is an orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis.

Benzinga

FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease

InflaRx N.V. (NASDAQ: IFRX) has

Tribune News Service

As abortion pills take off, some states move to curb them

In June, the U.S. Supreme Court is expected to weaken or topple its nearly 50-year-old abortion rights decision, Roe v. Wade, giving states wide latitude to restrict the procedure.

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