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The Latest Breaking News from FDA

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.

Benzinga

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.

Tribune News Service

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

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Covid shots for children under five pushed back by Pfizer

Company says it will now not have data on third dose protection until April

The Independent UK

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.

Axios

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.

Roll Call

Why Are Senseonics Shares Falling Despite FDA OK For Next-Gen Eversense CGM

The FDA has approved Senseonics Holdings Inc's (NYSE:

Benzinga

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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

Benzinga

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’

The Guardian - US

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

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

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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.

ABC News

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.

Benzinga

Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

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

The Independent UK

FDA may halt approval on cancer drugs developed in China

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

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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

Benzinga

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.

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.

Benzinga

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

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