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The Latest Breaking News from Food and Drug Administration

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

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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

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

The Independent UK

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.

Benzinga

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.

Bangkok Post

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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.

Benzinga

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.

McClatchy Washington Bureau

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…

Los Angeles Times

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…

Tribune News Service

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.

McClatchy Washington Bureau

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.

Tribune News Service

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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

The Guardian - US

Jury finds New York Times did not defame Sarah Palin – as it happened

Former Republican vice-presidential nominee sued the newspaper in 2017 claiming an editorial damaged her career

Bangkok Post

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.

Tribune News Service

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…

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McClatchy Washington Bureau

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.

The Independent UK

FDA's agenda in limbo as Biden's nominee stalls in Senate

President Joe Biden’s pick to lead the powerful Food and Drug Administration has stalled in the narrowly divided Senate

Tribune News Service

Wyden probes FDA nominee’s views on accelerated drug approvals

WASHINGTON — Senate Finance Chair Ron Wyden, D-Ore., is pressing the White House’s nominee to lead the Food and Drug Administration, Robert Califf, to pledge to crack down on drugmakers’ use of fast-track approval pathways as the nominee seeks the chairman’s support.

The Times of India

Pune private hospitals more equipped with medical oxygen: Food and Drug Administration

PUNE: Private hospitals in the district were better equipped on the medical oxygen availability front as compared to the civic hospitals, said the Food and Drug Administration.

Tribune News Service

Q&A: What to know about Pfizer’s COVID-19 vaccine for kids under age 5

The Food and Drug Administration said Tuesday it will consider authorizing Pfizer’s COVID-19 vaccine for kids as young as 6 months, opening the door to immunizing some 23 million American children for whom vaccines haven’t yet been available.

Asharq Al-Awsat

Pfizer Seeks US Approval of Covid Vaccine for Children under 5

Pfizer and BioNTech said Tuesday they are seeking emergency authorization from US health regulators for use of their Covid vaccine for children aged over six months and under five years. If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will become the first Covid vaccine available to…

Tribune News Service

Groups seek to shape final rule to ease hearing aid accessibility

WASHINGTON — The Food and Drug Administration is working to finalize a rule that would make it easier for many adults to get hearing aids, a policy change five years in the making that is sparking intense lobbying.

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