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The Latest Breaking News from FDA

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.

ABC News

Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

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

Benzinga

FDA may halt approval on cancer drugs developed in China

Drugs produced in China account for a significant share of the US market

The Independent UK

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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

The Independent UK

What Is Happening With Pulse Biosciences Stock Today?

Pulse Biosciences Inc (NASDAQ: PLSE) shares are tumbling after

Benzinga

Cannabis Marketing: Brands And Adult Consumption Trends In The US

By Nicolas Jose Rodriguez Via El Planteo.

Benzinga

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.

Tribune News Service

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FDA Gives Green To Check-Cap's Pivotal Study For Capsule-Based Colorectal Cancer Screening Test

The FDA has approved Check-Cap Ltd's (NASDAQ:

Benzinga

NGM Bio Shares Rise After Vision Disorder Candidate Receives FDA Fast Track Tag

The FDA has granted Fast Track designation to NGM Biopharmaceuticals Inc's

Benzinga

Dermata Therapeutics Shares Plunge 20% Premarket: What Investors Need To Know

Dermata Therapeutics Inc (NASDAQ: DRMA) has requested the FDA to waive the requir

Benzinga

Kids' vaccines create a new dilemma for federal officials

They'll have to decide whether to authorize shots for small children with incomplete data.

Axios

Wyden probes FDA nominee's views on accelerated drug approvals - Roll Call

Support from Wyden could be crucial to Robert Califf's FDA confirmation amid concerns from other Senate Democrats.

Roll Call

Americans exposed to toxic BPA at levels far above what EU considers safe – study

Petition urges FDA to strongly limit use of BPA, which is linked to cancer and other health problems

The Guardian - US

Hawaii, New York enact new congressional district maps; Pennsylvania Supreme Court assumes control over redistricting

Our weekly summary of federal news highlights redistricting updates in Hawaii, New York, and Pennsylvania, and the FDA approving the Moderna COVID-19 vaccine. Read all about it in this week’s edition of the Federal Tap.

Ballotpedia

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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.

Benzinga

The Daily Biotech Pulse: Big Pharma Earnings Prove Lackluster, Mersana Inks $1B ADC R&D Deal, Syros Gets Orphan Drug Designation

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

Bangkok Post

Police raid sausage factory after 9 children hospitalised

Consumer protection police raided a sausage factory in Chon Buri and seized products worth about 700,000 baht for examination after children in five provinces developed a blood disorder after eating food produced there.

The Independent UK

Sleep expert weighs in on America’s increased use of melatonin to sleep

Melatonin is an over-the-counter sleep aid that’s loosely regulated by the FDA

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Benzinga

Why Did LogicBio Therapeutics Shares Plunge To 52-Week Low Today?

The FDA has placed a clinical hold on LogicBio Therapeutics Inc's (NASDAQ:

Benzinga

Stock Wars: Axsome Therapeutics Vs. Global Blood Therapeutics

Benzinga’s weekly Stock Wars matches up two leaders in a major industry sector with the goal of determining which company is the better investment.

The Independent UK

EXPLAINER: COVID vaccines for kids under 5: What's next?

COVID-19 vaccines for kids under 5 may be available in the U.S. as early as March, but there are several hurdles still to clear

Benzinga

Flora Growth's New CBD Formulation To Prevent Infection From COVID 19, Pending Regulatory Approval To Launch Clinical Trials

Cannabis producer Flora Growth Corp. (NASDAQ: FLGC) announced today that its seeking approval from INVIMA, the Colombian FDA, to begin research on their patent-pending, cannabinoid-based product, citing recent studies stating the possibility of cannabinoids to display viral inhibition.

Benzinga

FDA Asks Pfizer - BioNTech To Submit For COVID-19 Vaccine Emergency Use Nod For Youngest Children

Pfizer Inc (NYSE: PFE) and its partner BioNTech SE (NASDAQ: BNTX) have

The Guardian - US

Pfizer seeks US authorization of Covid vaccine for children under five

FDA decision could come within weeks but big obstacles remain to getting all children inoculated

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…

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