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The Latest Breaking News from FDA

Senate sets up Califf confirmation vote with narrow procedural win - Roll Call

The nominee to lead the FDA, Robert Califf, survived a Senate procedural vote Monday with the help of five Republicans.

Roll Call

Why Pfizer Shares Are Trading Lower Today

Pfizer Inc (NYSE: PFE) is trading lower Monday after the U.S. Food and Drug Administration (FDA) requested additional data before approving its COVID-19 vaccine for children aged six months to four years old.

Benzinga

Why BioNTech Shares Are Falling Today

BioNTech SE (NASDAQ: BNTX) is trading lower Monday morning after the U.S. Food and Drug Administration (FDA) requested additional data before approving its COVID-19 vaccine for children aged six months to four years old.

Benzinga

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

FDA Clears Cidara Therapeutics' Phase 1 Trial For Immunotherapeutic Antiviral For Influenza

The

Benzinga

Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program

As previously announced, Denali Therapeutics Inc (NASDAQ: DNLI) was informed via e-mail communication from the FDA that DNL919 (ATV:TREM2) Investigational New Drug (IND) application was placed on clinical hold.

Benzinga

New monoclonal antibody drug for COVID-19 authorized, FDA says. It works against omicron

A new monoclonal antibody drug has proved to be effective against the coronavirus omicron variant and omicron subvariant, according to the Food and Drug Administration.

McClatchy Washington Bureau

Experts praise Pfizer's delay on kids' vaccines

Experts say waiting for data on three doses is the right call.

Axios

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Covid vaccine for young kids delayed

The FDA says it needs more time to review data on a potential three-dose vaccine for children aged 6 months to four

Salon

FDA AdComm Votes Against Lilly's Lung Cancer Drug, Sintilimab

The FDA advisory committee voted against the full approval of Eli Lilly And Co's (NYSE: LLY) lung cancer treatment over concerns that the clinical trial was conducted only in China and that its results did not apply to U.S. patients.

Benzinga

FDA postpones meeting on Pfizer COVID shot for kids under 5

U.S. health officials postponed a meeting of advisers on Pfizer Inc.’s COVID-19 vaccine for children under age 5, after the drugmaker said it has new data to add to its application for clearance.

Tribune News Service

Delay ahead for Pfizer's COVID-19 vaccine for kids under 5

U.S. regulators have put the brakes on their push to speed Pfizer’s COVID-19 to children under 5

The Independent UK

Covid shots for children under five pushed back by Pfizer

Company says it will now not have data on third dose protection until April

The Independent UK

Pfizer postpones FDA request for COVID vaccine for kids under 5

The companies said they will wait for more data on three doses for children under 5.

Axios

FDA seeks more data before reviewing COVID-19 vaccine for toddlers

The FDA postponed a Feb. 15 review of the Pfizer shots for young children ages 6 months to 4 years old, citing the need for more time.

Roll Call

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Benzinga

Why Are Senseonics Shares Falling Despite FDA OK For Next-Gen Eversense CGM

The FDA has approved Senseonics Holdings Inc's (NYSE:

Benzinga

India Globalization Capital Posts Net Loss Of $2.38M For The Third Quarter

India Globalization Capital, Inc. (AMEX:IGC) announced its financial results for the three months ending December 31, 2021 – quarter three of the company’s 2022 fiscal year. Q3 Financial Highlights

The Guardian - US

Michigan beef found to contain dangerous levels of ‘forever chemicals’

Contamination at a small farm discovered after sewage sludge was tested for PFAS, but officials downplayed incident as ‘isolated’

Asharq Al-Awsat

US FDA Advisers Say More Data Needed for Cancer Drug Tested in China

A panel of outside advisers to the US Food and Drug Administration on Thursday voted to recommend that Innovent Biologics Inc and Eli Lilly and Co be required to conduct a trial of their lung cancer drug that is applicable to the US population. Data submitted to the FDA for…

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news in one place.

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Benzinga

US Plans COVID-19 Vaccine Roll Out For Kids Under 5 Years This Month

The U.S. government is planning a COVID-19 vaccine roll out for children under the age of 5 as soon as February 21, according to a document from the U.S.

Benzinga

BTCY: Initiating Coverage – Outpatient Remote Cardiac Health Monitoring & Ecosystem with Emerging Growth Company Profile

By T. Moore, CFA NASDAQ:BTCY READ THE FULL BTCY RESEARCH REPORT

Benzinga

Sanofi - Regeneron's Dupixent Under FDA Priority Review For Children Under 5 Years With Atopic Dermatitis

The

Benzinga

The Daily Biotech Pulse: AstraZeneca Q4 Gets COVID Boost, Seagen Plunges On Earnings, Adcom Test Awaits Lilly

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

Benzinga

FDA Will Foster Development Of Non-Addictive Alternatives To Opioids For Pain: Should Cannabis Be On The List?

The U.S. Food and Drug Administration (FDA) announced Wednesday that it is taking steps aimed to foster the development of non-addictive alternatives to opioids to manage acute pain and prevent new addiction. The agency issued draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain.

ABC News

A COVID vaccine for children under five is one step closer. Here are five key questions that need answering

Children under five in the US could be getting vaccinated against COVID-19 as soon late February. Here's what we know so far about the jab, and what might happen next.

Benzinga

Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

Gamida Cell Ltd (NASDAQ: GMDA) has initiated the Biologics License Application (BLA)

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