FDA

GSK nabs speedy review for one of its top prospects
GSK nabs speedy review for one of its top prospects
Fierce Biotech
GSK
FDA
priority review
BCMA
belantamab mafodotin
relapsed or refractory multiple myeloma
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Will the FDA give the go-ahead to a prescription video game? The wait goes on, as new data come in
Will the FDA give the go-ahead to a prescription video game? The wait goes on, as new data come in
Stat
ADHD
FDA
video games
Akili Interactive
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House Committee Quizzes FDA on Complex Generic Drugs
House Committee Quizzes FDA on Complex Generic Drugs
RAPS.org
US Congress
FDA
Stephen Hahn
generics
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AstraZeneca’s Combination Treatment for HCC Snags Orphan Drug Designation
AstraZeneca’s Combination Treatment for HCC Snags Orphan Drug Designation
BioSpace
AstraZeneca
Imfinzi
orphan drugs
FDA
hepatocellular carcinoma
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OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show
OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show
RAPS.org
FDA
OAI
drug manufacturing
devices
device manufacturing
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BioCardia Fills in a Key Piece of CardiaAmp Puzzle with New Clearance
BioCardia Fills in a Key Piece of CardiaAmp Puzzle with New Clearance
Medical Devices and Diagnostics Industry
BioCardia
CardiAMP
cell therapy
FDA
DNA deflectable guide catheter
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While expected, Intercept's approval delay adds to NASH uncertainty
While expected, Intercept's approval delay adds to NASH uncertainty
BioPharma Dive
Intercept Pharma
NASH
FDA
obeticholic acid
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FDA to Allow Online Submissions of Orphan Designation Requests
FDA to Allow Online Submissions of Orphan Designation Requests
RAPS.org
FDA
orphan drugs
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FDA Committee Votes 6-6 on Durect's Non-Opioid Pain Drug
FDA Committee Votes 6-6 on Durect's Non-Opioid Pain Drug
BioSpace
FDA
Durect Corporation
painkillers
non-opioid pain treatments
Posimir
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Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication
Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication
Endpoints
Novo Nordisk
Ozempic
diabetes
cardiovascular events
FDA
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FDA Warns of Potential Contamination With Some Cardinal Health Surgical Gowns
FDA Warns of Potential Contamination With Some Cardinal Health Surgical Gowns
RAPS.org
FDA
product recalls
Cardinal Health
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Government spending bill tweak means 3 more NDAs will become BLAs, FDA says
Government spending bill tweak means 3 more NDAs will become BLAs, FDA says
Endpoints
legislation
regulatory
biologics
NDAs
BLAs
FDA
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Analysts tip Biogen to file for aducanumab approval within weeks
Analysts tip Biogen to file for aducanumab approval within weeks
Fierce Biotech
Biogen
Alzheimer's disease
aducanumab
FDA
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Novavax Wins Fast-Track Designation for Flu Vaccine
Novavax Wins Fast-Track Designation for Flu Vaccine
Motley Fool
Novavax
flu vaccines
vaccines
NanoFlu
FDA
fast track
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FDA Gives Clovis Oncology's Rubraca a Priority Review
FDA Gives Clovis Oncology's Rubraca a Priority Review
Motley Fool
Clovis Oncology
Rubraca
FDA
priority review
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Novartis Starts 2020 a Step Ahead of Other Big Pharmas with the Most Newly Approved Drugs
Novartis Starts 2020 a Step Ahead of Other Big Pharmas with the Most Newly Approved Drugs
Motley Fool
Novartis
FDA
drug approvals
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Nektar pulls NDA for pain drug after unanimous AdComm rejection
Nektar pulls NDA for pain drug after unanimous AdComm rejection
Fierce Biotech
Nektar Therapeutics
opioids
FDA
oxycodegol
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FDA staff highlight neurological safety concerns with Durect's pain drug
FDA staff highlight neurological safety concerns with Durect's pain drug
Endpoints
FDA
Durect
anesthesia
Posimir
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FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find
FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find
NPR
FDA
drug approvals
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FDA Warns of Potential Cancer Risk With Weight Loss Drug
FDA Warns of Potential Cancer Risk With Weight Loss Drug
RAPS.org
FDA
Belviq
Eisai
cancer
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