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The Latest Breaking News from FDA

The Daily Biotech Pulse: Sanofi-IGM Ink Antibody Drug Collaboration; NeoGenomics Sinks On CEO Departure, Q1 Warning; Decision Day For Akebia

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

Benzinga

50 Biggest Movers From Yesterday

Gainers Hycroft Mining Holding Corporation (NASDAQ: HYMC) shares gained 81.3% to close at $2.32 on Monday. Last week, AMC Entertainment Holdings purchased a major stake in Hycroft Mining Holding.

Benzinga

Amylyx Shares Plummet On Skeptical FDA Adcomm Docs On ALS Drug

The FDA released its briefing documents for the advisory committee to discuss Amylyx Pharmaceuticals Inc's (NASDAQ:AMLX) sodium phenylbutyrate/taurursodiol (AMX0035) powder for amyotrophic lateral sclerosis (ALS). Agency statisticians called into question the Company's efficacy and survival analyses, raising concern that the modest survival benefit seen may potentially be due to underlying disease heterogeneity rather than…

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

Covid-19 Play Pfizer Stock Nearing New Buy Point; Is It Worth Considering?

Pfizer stock may be the latest contender for your watchlist as shares set up to score a breakout from a new buy point.

Investors Business Daily

FDA skeptical of benefits from experimental ALS drug

The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease

The Independent UK

Mid-Day Market Update: Crude Oil Dips 8%; Plantronics Shares Spike Higher

U.S. stocks traded mixed midway through trading, with the Dow dropping 175 points on Monday.

Benzinga

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

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Amylyx Pharmaceuticals Stock Crashes As FDA Doubts Its ALS Treatment

The Food and Drug Administration cast doubt on Amylyx Pharmaceuticals' ALS treatment Monday, leading shares to plummet.

Investors Business Daily

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

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

Staar Surgical Rockets After FDA Clears Its Implantable Lens For Nearsightedness

Staar Surgical won Food and Drug Administration clearance for its implantable nearsightedness lens on Monday, leading STAA stock to soar.

Investors Business Daily

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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

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

Iterum Therapeutics plc (NASDAQ: ITRM) has incurred a

Inverse

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.

The Guardian - US

‘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

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news in one place.

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Tribune News Service

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.

Benzinga

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.

StockNews.com

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…

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

Investors Business Daily

Amylyx Stock Jumps As FDA Mulls ALS Drug — What To Know Ahead Of FDA Action

IPO stock Amylyx Pharmaceuticals surged Friday ahead of an important Food and Drug Administration meeting to discuss its ALS treatment.

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