FDA

Alnylam, with positive data on second gene-silencing drug, plans filing to FDA
Alnylam, with positive data on second gene-silencing drug, plans filing to FDA
Stat
Alnylam
gene-silencing
givosiran
FDA
acute hepatic porphyrias
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Opioids Compromise: What’s in it for FDA
Opioids Compromise: What’s in it for FDA
RAPS.org
opioids
opioid crisis
Senate
US Congress
FDA
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TG stock sinks after setback to blood cancer trial
TG stock sinks after setback to blood cancer trial
Fierce Biotech
TG Therapeutics
FDA
ublituximab-umbralisib
CLL
chronic lymphocytic leukemia
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Endo presses pause on litigation after FDA assurance to sort out compounding competition by year-end
Endo presses pause on litigation after FDA assurance to sort out compounding competition by year-end
Fierce Pharma
FDA
Endo Pharmaceuticals
compounded drugs
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Another Precision Step for Roche as Ignyta Drug Heads to Regulators
Another Precision Step for Roche as Ignyta Drug Heads to Regulators
Xconomy
Roche
entrectinib
Ignyta
FDA
non-small cell lung cancer
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FDA lifts clinical hold on Sarepta's Duchenne MD gene therapy, clearing the way to a quick launch of a pivotal trial
FDA lifts clinical hold on Sarepta's Duchenne MD gene therapy, clearing the way to a quick launch of a pivotal trial
Endpoints
Sarepta Therapeutics
FDA
gene therapy
Duchenne Muscular Dystrophy
clinical trials
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FDA gives Epizyme a green light on trial recruitment, but tazemetostat isn’t completely out of the woods yet
FDA gives Epizyme a green light on trial recruitment, but tazemetostat isn’t completely out of the woods yet
Endpoints
Epizyme
clinical trials
FDA
tazemetostat
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FDA panel to discuss how patients can improve medical device review
FDA panel to discuss how patients can improve medical device review
BioCentury
FDA
devices
patients
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Beyond the pale (ale): FDA orders pharma lab to can its microbrewery operation
Beyond the pale (ale): FDA orders pharma lab to can its microbrewery operation
Stat
FDA
warnings
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Acadia Pharma Soars After FDA Investigation Clears Nuplazid of Additional Safety Problems
Acadia Pharma Soars After FDA Investigation Clears Nuplazid of Additional Safety Problems
BioSpace
Acadia
FDA
Nuplazid
Parkinson's Disease Psychosis
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FDA may crack down on clinical trial reporting
FDA may crack down on clinical trial reporting
BioCentury
FDA
clinical trials
clinical trial data
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Pfizer's Pneumococcal Conjugate Vaccine Awarded Breakthrough Therapy Designation
Pfizer's Pneumococcal Conjugate Vaccine Awarded Breakthrough Therapy Designation
CP Wire
Pfizer
streptococcus pneumoniae
vaccines
breakthrough therapies
FDA
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FDA Smashes Record for Most ANDA Complete Responses in one Year
FDA Smashes Record for Most ANDA Complete Responses in one Year
RAPS.org
FDA
ANDAs
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Device Makers Call for Changes to FDA’s Biliary Stent Guidance
Device Makers Call for Changes to FDA’s Biliary Stent Guidance
RAPS.org
devices
Boston Scientific
Cook Medical
FDA
biliary stents
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Meditech Spine wins FDA nod for spinal implant system
Meditech Spine wins FDA nod for spinal implant system
Medical Design and Outsourcing
Meditech Spine
FDA
CURE Opel-C Plate spinal implant system
spinal impants
devices
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Genentech and Hemophilia Patients Eye Oct. 4 for Hemlibra Ruling
Genentech and Hemophilia Patients Eye Oct. 4 for Hemlibra Ruling
BioSpace
FDA
Genentech
Hemlibra
hemophilia
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FDA lifts clinical hold from Mersana’s breast cancer trial
FDA lifts clinical hold from Mersana’s breast cancer trial
Fierce Biotech
FDA
clinical trials
Mersana
antibody-drug conjugate
XMT-1522
breast cancer
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Roche's Child Arthritis Drug's New Formulation Gets FDA Nod
Roche's Child Arthritis Drug's New Formulation Gets FDA Nod
Yahoo/Zacks.com
Roche
Genentech
FDA
Actemra
systematic juvenile idiopathic arthritis
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FDA clears 1st acute coronary artery perforation stent in 17 years
FDA clears 1st acute coronary artery perforation stent in 17 years
Mass Device
FDA
Biotronik
coronary artery stent
PK Papyrus
devices
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Gottlieb releases FDA's plan to combat antibiotic resistance, calls for funding
Gottlieb releases FDA's plan to combat antibiotic resistance, calls for funding
BioCentury
FDA
Scott Gottlieb
antibiotic resistance
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