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The Latest Breaking News from FDA

The Daily Biotech Pulse: Larimar Plunges On Extension Of Clinical Hold, ImmunityBio Gains On Positive Data, Adcom Test Awaits Avenue Therapeutics

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

Benzinga

After the FDA issued warnings about antidepressants, youth suicides rose and mental health care dropped

Depression in young people is vastly undertreated. About two-thirds of depressed youth don’t receive any mental health care at all. Of those who do, a significant proportion rely on antidepressant medications.

The Conversation

Larimar Stock Plunges As FDA Asks For Additional Data To Resolve Clinical Hold On Friedreich's Ataxia Program

Larimar Therapeutics Inc (NASDAQ: LRMR) has rec

Benzinga

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Medical goods among B30m of fake products seized at warehouse

Consumer protection police and Food and Drug Administration (FDA) officials seized a large quantity of falsely labelled, sub-standard products worth about 30 million baht at a warehouse in Khlong Luang district, Pathum Thani province.

Bangkok Post

Commentary: What we can learn about cancer drug development from the COVID-19 approach

As an oncologist, I recognize the arduous path to make a new drug. It is a hard trek that lies between the bench and the patient’s bedside. Ordinarily, it takes five or more years just to get a new drug into the clinic for testing. Similar time is needed for…

Tribune News Service

Weed'n Whiskey: Why Tilray Thinks There Is Gold In Cannabis-Infused Whiskey

This article was originally published on Cannabis.net and appears here with permission.

Benzinga

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

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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

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

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

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Benzinga

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.

Tribune News Service

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.

The Independent UK

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

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Axios

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.

Roll Call

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.

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…

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.

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