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The Latest Breaking News from Food and Drug Administration

FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples

The Independent UK

Covaxin’s Phase 2/3 clinical trials put on hold in the US

HYDERABAD: The US Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s Covid-19 vaccine Covaxin in the US.

The Times of India

E-cigs using synthetic nicotine come under FDA oversight

The Food and Drug Administration says it will begin cracking down on e-cigarettes that have used synthetic nicotine to skirt oversight

The Independent UK

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Commentary: Is a second booster for COVID-19 the right choice for you?

The Food and Drug Administration and the Centers for Disease Control and Prevention recently authorized a second booster shot of the Pfizer/BioNTech and Moderna COVID-19 vaccines for those age 50 and older. The recommendation follows a study out of Israel recently published in The New England Journal of Medicine.

Chicago Tribune

New type of cigarette that ‘helps you smoke less’ debuts in Chicago stores this week, amid some controversy

Cigarettes that recently gained authorization from the Food and Drug Administration to be marketed as products that can help smokers cut back are hitting Chicago-area stores this week — the first place in the country where they will be sold.

Chicago Tribune

Why Biofrontera Stock Is Surging Today

Biofrontera Inc (NASDAQ: BFRI) shares are trading significantly higher Wednesday after the company announced it received U.S. Food and Drug Administration approval for its cGMP laboratory in Germany.

Benzinga

Why BriaCell Therapeutics Stock Is Surging Today

BriaCell Therapeutics Corp (NASDAQ: BCTX) shares are trading higher Wednesday after the company announced the U.S. Food and Drug Administration granted Fast Track status to Bria-IMT for the treatment of metastatic breast cancer.

Benzinga

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Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

Benzinga

Commentary: FDA shouldn’t approve ALS drug without more data

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.

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

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

FDA reviews ALS drug after lobbying by patients, politicians

The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

The Independent UK

Psyched: MindCure Shuts Down Operations, Novamind And MindMed Partner For Study

The psychedelics space was shaken up on the news that MindCure Health (OTC:MCURF) was shutting down operations. After a review process, the company’s board decided that MindCure’s business plan required more capital that it could gather under current market conditions, thus shutting down operations was considered the best move to preserve…

Benzinga

Moderna Seeks US Approval of Second Covid Booster

Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults. The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18…

Asharq Al-Awsat

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The Independent UK

Moderna seeks FDA authorization for 4th dose of COVID shot

Drugmaker Moderna has asked the Food and Drug Administration to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults

Benzinga

Wesana Health One Step Closer To Clinical Trials Of Psilocybin And CBD Based Treatment Of Brain Injury Related MDD

Wesana Health Holdings Inc. (OTCQB:WSNAF) (CSE:WESA) have received a full written response from the Food and Drug Administration regarding their pre-investigational new drug meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of traumatic brain injury related major depressive disorder.

Bangkok Post

Local Covid vaccines undergo human trials

Four out of more than 20 Covid-19 vaccine candidates being developed in Thailand are now being tested on humans, the final process required before they are submitted for approval by the Food and Drug Administration (FDA), the government said on Saturday.

Benzinga

Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates

The Food and Drug Administration approval calendar was light in February. Nevertheless, the month saw regulatory nods accorded to some breakthrough therapies.

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McClatchy Washington Bureau

Don’t use these 3 unauthorized COVID tests, FDA warns. You might get a false result

There are three COVID-19 tests distributed in the U.S. to avoid and if you already have any of them, don’t use them, the Food and Drug Administration is warning of the unauthorized tests.

Los Angeles Times

Commentary: The first treatment for Alzheimer’s taught us some hard lessons

The Food and Drug Administration’s surprise approval of Aduhelm for the treatment of Alzheimer’s disease last year was a mess on practically every level. Three agency advisers resigned, and skeptical doctors such as myself were left to advise patients — all desperate for hope — that, yes, it is a…

Tribune News Service

Mayo Clinic expert stresses importance of vaccinating school-age children for COVID-19

Parents hoping to get their young children vaccinated for COVID-19 will have to wait at least another two months. The Food and Drug Administration (FDA) recently postponed a decision on an emergency use authorization of the Pfizer vaccine for kids 6 months to 4 years old. The FDA is waiting…

McClatchy Washington Bureau

FDA says official suggesting annual COVID vaccines ‘does not work on vaccine matters’

A video has emerged of a Food and Drug Administration executive suggesting there are plans for annual COVID-19 vaccines to be implemented in the United States.

Tribune News Service

Mayo Clinic Minute: Hold the salt to help your heart

The Food and Drug Administration outlined new, voluntary guidelines to lower sodium levels in food. But those with high blood pressure or who are at risk for heart disease may want to consider simply saying no to sodium.

Tribune News Service

Senate confirms Robert Califf to become Biden’s FDA commissioner

WASHINGTON — The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

The Independent UK

Senate confirms Biden's FDA pick despite political divisions

The Senate has narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration, filling a position that had been open for more than a year

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