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The Latest Breaking News from FDA

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…

Asharq Al-Awsat

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

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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 The agency issued draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain.

Benzinga

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

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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

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

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

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news in one place.

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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

Axios

Kids' vaccines create a new dilemma for federal officials

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

Roll Call

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.

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news in one place.

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The Guardian - US

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

Ballotpedia

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.

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

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:

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