FDA

Acadia can’t shake off its Nuplazid nightmare
Acadia can’t shake off its Nuplazid nightmare
EP Vantage
Acadia
FDA
Nuplazid
antipsychotic
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FDA Seeks to Strike the Right Balance on Opioid Access
FDA Seeks to Strike the Right Balance on Opioid Access
RAPS.org
FDA
opioids
opioid crisis
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Valeant Pharma's (VRX) Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38%
Valeant Pharma's (VRX) Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38%
Street Insider
Valeant Pharmaceuticals
Bausch + Lomb
FDA
sub-micron loteprednol etabonate
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Intuitive Grabs FDA Nod and Makes a Play to Expand Its Presence
Intuitive Grabs FDA Nod and Makes a Play to Expand Its Presence
Medical Devices and Diagnostics Industry
devices
Intuitive Surgical
SureForm wristed staple
RTP
FDA
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Indications and Usage: FDA Issues Draft Labeling Guidance
Indications and Usage: FDA Issues Draft Labeling Guidance
RAPS.org
FDA
labeling
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3 Best Gene Therapy Stocks of 2018 (So Far)
3 Best Gene Therapy Stocks of 2018 (So Far)
Motley Fool
gene therapy
FDA
Sarepta Therapeutics
Solid Biosciences
Regnxbio
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How a New Emphysema Device Won FDA Approval in Six Months
How a New Emphysema Device Won FDA Approval in Six Months
Medical Devices and Diagnostics Industry
FDA
devices
emphysema
Pulmonx
Zephyr endobronchial valve
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FDA Finalizes Guidance on GDUFA II
FDA Finalizes Guidance on GDUFA II
RAPS.org
FDA
generics
GDUFA
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FDA Limits the Use of Tecentriq and Keytruda
FDA Limits the Use of Tecentriq and Keytruda
RAPS.org
FDA
Roche
Merck
Tecentriq
Keytruda
metastatic urothelial cancer
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FDA calls Pfizer Estring marketing misleading
FDA calls Pfizer Estring marketing misleading
Biopharma Dive
FDA
OPDP
Pfizer
Estring
drug ads
DTC ads
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3 Biotech Stocks With Major Catalysts Incoming
3 Biotech Stocks With Major Catalysts Incoming
Motley Fool
Spark Therapeutics
Zogenix
Progenics Pharmaceuticals
SPK-8011
ZX008
Azedra
FDA
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Mylan plant slapped with 32-page FDA Form 483
Mylan plant slapped with 32-page FDA Form 483
Fierce Pharma
Mylan Labs
FDA
drug manufacturing
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CBD Oil Products Were Already Readily Available – How is Epidiolex Different?
CBD Oil Products Were Already Readily Available – How is Epidiolex Different?
CP Wire
CBD
Epidiolex
GW Pharma
FDA
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CBD Oil Products Were Already Readily Available – How is Epidiolex Different?
CBD
Epidiolex
GW Pharma
FDA
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After closing the gap on new hires, FDA could face an exodus of top regulators
After closing the gap on new hires, FDA could face an exodus of top regulators
Endpoints
FDA
Scott Gottlieb
21st Century Cures Act
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FDA Grants Priority Review to Keytruda Combination Therapy for Metastatic Squamous Non-Small Cell Lung Cancer
FDA Grants Priority Review to Keytruda Combination Therapy for Metastatic Squamous Non-Small Cell Lung Cancer
CP Wire
Merck
Keytruda
non-small cell lung cancer
metastatic squamous non-small cell lung cancer
priority review
FDA
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Ocular Therapeutix resubmits NDA for ocular pain relief implant
Ocular Therapeutix resubmits NDA for ocular pain relief implant
Drug Delivery Business News
Ocular Therapeutix
ocular pain relief
FDA
Dextenza
devices
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FDA chief on Amazon's health-care move: 'Disruptive competition is a good thing'
FDA chief on Amazon's health-care move: 'Disruptive competition is a good thing'
CNBC
Amazon
M&A
PillPack
FDA
Scott Gottlieb
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Acne was a bust, but excessive sweating scores FDA OK for Dermira — shares climb
Acne was a bust, but excessive sweating scores FDA OK for Dermira — shares climb
Endpoints
Dermira
FDA
glycopyrronium
Qbrexza
excessive sweating
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Valeant signs with WorldMeds to hawk first-ever opioid withdrawal drug Lucemyra
Valeant signs with WorldMeds to hawk first-ever opioid withdrawal drug Lucemyra
Fierce Pharma
US WorldMeds
FDA
Lucemyra
opioid withdrawal
Valeant Pharmaceuticals
Salix
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