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FDA approves GE’s AI-based collapsed lung detection system

FDA approves GE’s AI-based collapsed lung detection system

Pharmaforum

Criticial Care Suite

artificial intelligence

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First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation

First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation

Medical Devices and Diagnostics Industry

breakthrough status

Active Implants

meniscus surgery

artificial meniscus

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GSK's oral nicotine spray wins divided FDA panel's backing despite abuse risks

GSK's oral nicotine spray wins divided FDA panel's backing despite abuse risks

Fierce Pharma

advisory panels

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FDA needs to recall Zantac and other ranitidine antacids, says pharmacy that uncovered impurity

FDA needs to recall Zantac and other ranitidine antacids, says pharmacy that uncovered impurity

Fierce Pharma

product recalls

citizen petitions

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FDA Lays Out Tech Modernization Action Plan

FDA Lays Out Tech Modernization Action Plan

RAPS.org

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Merck's Ebola vaccine tees up FDA date, aiming for first status

Merck's Ebola vaccine tees up FDA date, aiming for first status

Fierce Biotech

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Scott Gottlieb is once again joining a team that enjoyed good times at the FDA under his high-energy stint at the helm

Scott Gottlieb is once again joining a team that enjoyed good times at the FDA under his high-energy stint at the helm

Endpoints

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AstraZeneca diabetes drug granted fast track status for heart failure treatment

AstraZeneca diabetes drug granted fast track status for heart failure treatment

Yahoo/Reuters

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The Week Ahead In Biotech: Novo Nordisk And Merck Await FDA Rulings, 2 IPOs On Deck

The Week Ahead In Biotech: Novo Nordisk And Merck Await FDA Rulings, 2 IPOs On Deck

Yahoo/Benzinga

oral semaglutide

Kodiak Sciences

MeiraGTx Holdings

IGM Biosciences

Arrowhead Pharmaceuticals

Lexicon Pharmaceuticals

vTv Therapeutics

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Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

RAPS.org

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Ardelyx bags its first FDA OK for IBS, setting up a showdown with Allergan, Ironwood

Ardelyx bags its first FDA OK for IBS, setting up a showdown with Allergan, Ironwood

Endpoints

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Zantac and some OTC meds found to contain suspected carcinogen first discovered in blood pressure drugs

Zantac and some OTC meds found to contain suspected carcinogen first discovered in blood pressure drugs

Fierce Pharma

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Aimmune's peanut allergy drug secures FDA panel support, along with criticism

Aimmune's peanut allergy drug secures FDA panel support, along with criticism

Biopharma Dive

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Amgen shares hit after analysts expose buried FDA trial halt

Amgen shares hit after analysts expose buried FDA trial halt

Fierce Biotech

clinical trials

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Glaxo's Asthma Drug Nucala Gets FDA Nod for Pediatric Use

Glaxo's Asthma Drug Nucala Gets FDA Nod for Pediatric Use

Yahoo/Zacks.com

eosinophilic asthma

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Study: How Dependable Are Surrogate Endpoints?

Study: How Dependable Are Surrogate Endpoints?

Xtalks

clinical trials

surrogate endpoints

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An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening

An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening

Stat

advisory panels

Aimmune Therapeutics

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Aspen's drug to prevent preterm birth approved by FDA

Aspen's drug to prevent preterm birth approved by FDA

Reuters

Aspen Pharmacare

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FDA corrects claims by Sprout Pharmaceuticals about its libido-boosting drug

FDA corrects claims by Sprout Pharmaceuticals about its libido-boosting drug

News and Observer, NC

Sprout Pharmaceuticals

female sexual dysfunction

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Pfizer hires ex-FDA, MD Anderson researcher as clinical oncology lead

Pfizer hires ex-FDA, MD Anderson researcher as clinical oncology lead

Fierce Biotech

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