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The Latest Breaking News from FDA

Antares Pharma's Oral Testosterone Treatment Scores FDA Approval

Antares Pharma Inc (NASDAQ:ATRS) has nabbed another FDA approval, and the Company's second involving testosterone. The Company announced FDA approval for Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy indicated for deficiency or absence of endogenous testosterone or hypogonadism. The first time the Company got a testosterone product approved by…

Benzinga

Ocuphire Pharma's Shares Fall Despite Positive Data From Registrational Phase 3 Trial Of Nyxol

Ocuphire Pharma Inc (NASDAQ:OCUP) announced topline results from the second Phase 3 MIRA-3 trial of Nyxol to reverse pharmacologically-induced mydriasis (dilation of the pupil). The trial met its primary endpoint, with 58% of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter (PD) at 90 minutes…

Benzinga

US FDA approves second Covid booster for Americans 50 and older

Immunocompromised people also eligible for second booster, with CDC now to decide how and when such doses are offered

The Guardian - US

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FDA clears way for millions to get additional COVID-19 boosters

U.S. regulators cleared second booster doses of COVID-19 vaccine from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

Tribune News Service

FDA clears way for millions to get additional COVID-19 boosters

Tribune News Service

FDA approves another COVID booster for 50 and up

The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster.

Chicago Sun-Times

FDA approves another Pfizer, Moderna Covid booster for 50 and up

US regulators are allowing people 50 and older to get another booster dose of the Pfizer or Moderna Covid-19 vaccine

The Independent UK

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Why Novo Nordisk Shares Are Trading Higher Today

The FDA has approved Novo Nordisk A/S's (NYSE:NVO) 2.0 mg dose of Ozempic (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analog for type 2 diabetes. Ozempic is now approved in the US at 0.5 mg,1.0 mg, and 2.0 mg doses to treat type 2 diabetes in adults. Further, Ozempic is indicated to…

Benzinga

Biden and allies vow to keep up Russia punishment for ‘brutal attacks in Ukraine’ – as it happened

US and European leaders pledge assistance for people inside Ukraine and for those fleeing country

The Guardian - US

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

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

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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

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…

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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

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

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.

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