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The Latest Breaking News from FDA

The Daily Biotech Pulse: Roche's Lung Cancer Combo Therapy Flunks Late-Stage Study, Adagio Spikes On Positive COVID Antibody Data, Amylyx Awaits Adcom Verdict

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

Benzinga

Omicron BA.2 Variant Represents More Than 50% COVID-19 Cases, Says CDC Estimates: WSJ

According to the Centers for Disease Control and Prevention estimates, the omicron BA.2 variant represents approximately 55% of new COVID-19 cases in the U.S., as signs suggest infections are edging higher again in parts of the Northeast.

Benzinga

America's choose-your-own-adventure vaccine approach could create confusion

The gap between the under-vaccinated and the ultra-vaccinated will continue to grow.

Axios

From analysis to the latest developments in health,
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53 Biggest Movers From Yesterday

Gainers

Benzinga

Big Pharma is betting on bigger political ambitions from Sen. Tim Scott

Sen. Tim Scott, a rising star in the Republican Party with broad popularity in his home state of South Carolina, is getting showered with drug industry money before facing voters this fall.

Tribune News Service

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

WASHINGTON — 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

CBD Is Expensive, How The Industry Can Re-Think Its Pricing For Consumers

By Alejandro Bergad The last two years haven’t been great for the CBD industry. The pandemic cratered in-store sales of CBD. Meanwhile, by choosing not to regulate CBD, the FDA left it in a legal gray area, limiting where it can be sold.

Benzinga

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Here's Why Moderna Shares Are Rising

Moderna Inc (NASDAQ: MRNA) shares are trading higher by 4.67% at $181.16 after the company received FDA approval for Emergency Use Authorization for a second booster dose of its COVID-19 vaccine.

Benzinga

Infectious omicron BA.2 now dominant in US, with coronavirus spring rise likely

LOS ANGELES — The highly infectious BA.2 omicron subvariant is now the dominant version of the coronavirus circulating in the United States, according to federal estimates, a development that is triggering fresh concerns of a potential springtime wave.

Los Angeles Times

How does the COVID-19 prevention drug Evusheld work and who should receive it? An infectious disease specialist explains

The U.S. Food and Drug Administration granted emergency use authorization to AstraZeneca’s COVID-19 antibody drug Evusheld on Dec. 8, 2021. Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.

The Conversation

FDA Approves ViiV Healthcare's Cabenuva For Virologically Suppressed Adolescents With HIV

The FDA has approved ViiV Healthcare's Cabenuva (cabotegravir, rilpivirine) for HIV-1 in virologically suppressed adolescents. The approval covers patients aged 12 years or older and weighing at least 35kg on a stable antiretroviral regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. The regimen…

Benzinga

3 Healthcare Stocks to Buy for the Long Run

The healthcare industry has achieved significant growth over the past two years in-part because the COVID-19 pandemic fostered a stream of hefty private and federal investments in the sector. With accelerating advancement and increased tech integration in healthcare, we expect renowned companies Pfizer Inc. (PFE), Merck & Co., Inc. (MRK),…

StockNews.com

US regulators approve 2nd COVID booster for those aged 50 and up

US has seen a small uptick in new COVID-19 cases over the past week, raising concern that infections could surge again.

Al Jazeera

FDA Authorizes Fourth Dose Of Moderna, Pfizer/BioNTech COVID-19 Vaccines For Older People

The FDA has approved a second round of the Moderna Inc (NASDAQ:

Benzinga

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Investors Business Daily

Moderna, BioNTech Pop After FDA OKs Another Covid Booster Round — But Not For Everyone

Vaccine stocks jumped Tuesday after the FDA authorized another round of Covid booster shots for people age 50 and older.

Benzinga

36 Stocks Moving In Tuesday's Mid-Day Session

Gainers China SXT Pharmaceuticals, Inc. (NASDAQ: SXTC) jumped 88.1% to $0.38 after declining 9% on Monday.

Benzinga

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…

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The Guardian - US

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

Tribune News Service

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

Chicago Sun-Times

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.

The Independent UK

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

Benzinga

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…

The Guardian - US

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

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