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The Latest Breaking News from FDA

35 Stocks Moving In Monday's Mid-Day Session

Gainers Hycroft Mining Holding Corporation (NASDAQ: HYMC) jumped 57.1% to $1.96 following reports regarding potential future investments from AMC CEO, Adam Aron.

Benzinga

UCB's Rare Childhood Epilepsy Drug Scores FDA Approval

The FDA approved UCB SA's (OTC:UCBJY) drug to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of childhood epilepsy. The drug, branded as Fintepla, is approved in the U.S. to treat another form of childhood-onset epilepsy, Davet Syndrome (DS), in patients aged two years and older. LGS causes cognitive dysfunction and…

Benzinga

Why STAAR Surgical's Shares Are Gaining Today

The FDA approved STAAR Surgical Company's (NASDAQ:STAA) EVO/EVO+ Visian Implantable Collamer Lens to correct myopia and myopia with astigmatism. Myopia, also known as nearsightedness or the need for distance vision correction. The Company, in a statement, says that the EVO lens is additive, provides quality of vision day & night, does not cause…

Benzinga

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MindMed Reports Full Year 2021 Financial Results, Announces Changes In Leadership

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (NEO: MMED) reported its financial results for the full year ended December 31, 2021. 2021 Financial Results Cash balance as of December 31, 2021, was $133.5 million compared to $80.1 million as of December 31, 2020. Net cash in operating activities was $45.8 million for…

Benzinga

Mid-Morning Market Update: Markets Mixed; SAIC Profit Tops Views

U.S. stocks traded mixed this morning, with the Dow dropping around 100 points on Monday.

Benzinga

FDA Says Current Dose Of GSK-Vir's COVID-19 Therapy Unlikely To Work Against Omicron Subvariant

The FDA said that the currently authorized 500mg dose of GlaxoSmithKline Plc (NYSE:GSK) and Vir Biotechnology Inc's (NASDAQ:VIR) COVID-19 antibody therapy is unlikely to be effective against the omicron BA.2 variant. The agency updated its website to exclude sotrovimab use in geographic regions where the infection is likely caused by the omicron BA.2 variant. GSK…

Benzinga

FDA-Authorized Reduced-Nicotine Cigarette From 22nd Century Group That 'Helps You Smoke Less' To Reach Illinois

22nd Century Group, Inc. (NASDAQ:XXII) received notification from the Office of the Illinois Attorney General's Tobacco Enforcement Bureau that its VLN cigarettes will be listed in the Illinois Directory of Participating Manufacturers effective April 4, 2022.

Benzinga

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Iterum Expects To Start Additional Sulopenem Trial In Urinary Tract Infections In 2H22

Iterum Therapeutics plc (NASDAQ: ITRM) has incurred a

Benzinga

Artificial sweeteners cause cancer in mice. Here's worrying data from humans.

In a new study, researchers used data from over 100,000 people to better pinpoint whether consumption of artificial sweeteners is linked with an increased risk of cancer in humans.

Inverse

‘We’re way behind’: next US booster rollout faces delays and lack of funds

With a potential second booster on the horizon for vulnerable groups, the White House is still struggling to drum up interest for additional shots – and funding

The Guardian - US

US to clear additional booster shot against COVID-19

The U.S. Food and Drug Administration is poised to clear a fourth dose of the mRNA coronavirus vaccine for adults age 50 and older, looking to shore up protections for more vulnerable groups, a person familiar with the matter said.

Tribune News Service

Analyst on Charlotte's Web: 'We Stay Neutral, But Do Keep An Eye On This CBD Sector Bellwether Stock'

The Analyst

Benzinga

Mid-Afternoon Market Update: Dow Falls 30 Points; Cutera Shares Spike Higher

U.S. stocks traded lower toward the end of trading, with the Nasdaq Composite dropping more than 100 points on Friday.

Benzinga

3 Vaccine Stocks to Buy Following the Surge in COVID-19 Cases in China

China is battling with its worst COVID-19 outbreak since 2020. Surging cases of a new omicron variant worldwide are raising concerns that another COVID-19 wave is coming, which could drive demand for future vaccine orders. This bodes well for popular vaccine stocks Pfizer (PFE), Moderna (MRNA), and BioNTech (BNTX), and…

StockNews.com

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Benzinga

Analysts Cut Price Target On MEI Pharma As Stock Falls To 52-Week Low After Zandelisib Update

The FDA crushed MEI Pharma Inc's (NASDAQ: MEIP) hopes of winning accelerated approval for its PI3K inhibitor, zandelisib, on the strength of phase 2 data.

The Independent UK

FDA advisory panel to discuss Covid-19 boosters: What we know so far

Pfizer and Moderna seek approval for second ‘booster’ doses as White House warns US has exhausted funding to buy more shots

Benzinga

Mid-Day Market Update: Nasdaq Down 1%; Icosavax Shares Plummet

U.S. stocks pared gains midway through trading, with the Nasdaq Composite dropping 1% on Friday.

Benzinga

36 Stocks Moving In Friday's Mid-Day Session

Gainers Forge Global Holdings, Inc. (NYSE: FRGE) shares jumped 66.4% to $20.70.

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Benzinga

EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck & Co Inc (NYSE: MRK) for

Benzinga

U.S. Senate Green-Lights Bipartisan Marijuana Research Bill Ahead Of House Legalization Vote

On Thursday, the Senate gave a green light to a bipartisan marijuana bill meant to promote marijuana research, reported Marijuana Moment.

Benzinga

Why Cutera's Shares Are Soaring Today

The FDA has granted 510(k) clearance to Cutera Inc's (NASDAQ:CUTR) AviClear for acne. The Company notes that AviClear is the first and only energy-based device to receive this designation to treat mild, moderate, and severe acne. AviClear is a laser treatment that offers a safe, prescription-free solution for acne. In addition to reducing existing acne,…

Benzinga

FDA Pushes Bristol Myers' Reblozyl Decision Date In Non-Transfusion Dependent Beta Thalassemia

The

The Conversation

Drugs that treat opioid use disorder are a good use for multibillion-dollar settlement funds

States, cities, counties and tribal governments across the nation will soon receive a windfall through several major opioid settlements. Drug distributors and manufacturers, including Purdue Pharma and the Sackler family members who own it, will relinquish a total of about US$32 billion for their role in the overdose crisis. Other…

Benzinga

The Daily Biotech Pulse: MEI Pharma Wilts On Adverse Regulatory Development, Decision Day For Zogenix, AN2 Therapeutics IPO

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

Benzinga

34 Stocks Moving in Friday's Pre-Market Session

Gainers Clever Leaves Holdings Inc. (NASDAQ: CLVR) rose 40.5% to $2.22 in pre-market trading after the company reported better-than-expected Q4 sales results and reaffirmed FY22 guidance.

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