FDA

FDA Awards Regenerative Medicine Advanced Therapy Designation to Caladrius' Refractory Angina Treatment
FDA Awards Regenerative Medicine Advanced Therapy Designation to Caladrius' Refractory Angina Treatment
CP Wire
Caladrius Biosciences
FDA
refractory angina
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Valeant shares drop 5% after FDA fails to approve plaque psoriasis lotion
Valeant shares drop 5% after FDA fails to approve plaque psoriasis lotion
Marketwatch
Valeant Pharmaceuticals
psoriasis
FDA
Duobrii
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Despite FDA hold, Epizyme’s tazemetostat posts positive interim data
Despite FDA hold, Epizyme’s tazemetostat posts positive interim data
Fierce Biotech
Epizyme
tazemetostat
follicular lymphoma
FDA
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Indivior shares dive after Dr Reddy's gets FDA approval for generic
Indivior shares dive after Dr Reddy's gets FDA approval for generic
Reuters
Indivior
FDA
generics
Suboxone Film
opioids
opioid addiction
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FDA advisory panel turns down PneumRx’s Elevair lung implant
FDA advisory panel turns down PneumRx’s Elevair lung implant
Fierce Biotech
FDA
advisory panels
PneumRx
Elevair
lung implants
emphysema
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Medtronic wins FDA nod for new lengths of drug-coated balloon
Medtronic wins FDA nod for new lengths of drug-coated balloon
Drug Delivery Business News
Medtronic
FDA
IN.PACT Admiral
devices
drug-coated balloons
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GSK wins yet another reprieve for blockbuster Advair franchise as Mylan is hit (again) with a CRL
GSK wins yet another reprieve for blockbuster Advair franchise as Mylan is hit (again) with a CRL
Endpoints
Mylan
FDA
Advair
GSK
complete response letter
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FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease
FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease
Drug Delivery Business News
Sunovion
FDA
Parkinson's Disease
Apomorphine
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FDA permits more expansive communication between drugmakers, payers
FDA permits more expansive communication between drugmakers, payers
Biopharma Dive
FDA
payers
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Merck's Keytruda snags I-O's first cervical cancer nod to back up HPV fighter Gardasil
Merck's Keytruda snags I-O's first cervical cancer nod to back up HPV fighter Gardasil
Fierce Pharma
Merck
Keytruda
FDA
cervical cancer
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FDA Chief Proposes New Pricing Model and Cites New Guidelines to Spur Antibiotic Development
FDA Chief Proposes New Pricing Model and Cites New Guidelines to Spur Antibiotic Development
CP Wire
FDA
Scott Gottlieb
antibiotic resistance
drug development
bacteriophage
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Biotech Executives Fret Over Hassles And Uncertainties Of 'Right To Try'
Biotech Executives Fret Over Hassles And Uncertainties Of 'Right To Try'
Forbes
FDA
Scott Gottlieb
biotech
right-to-try laws
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Sun Pharma gets reprieve as FDA clears key Halol plant
Sun Pharma gets reprieve as FDA clears key Halol plant
Biopharma Dive
Sun Pharma
drug manufacturing
Halol
FDA
India
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Senator Johnson Wants to Weaken the FDA – We Asked Why
Senator Johnson Wants to Weaken the FDA – We Asked Why
CP Wire
FDA
right-to-try laws
Senate
Senator Ron Johnson
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Senator Johnson Wants to Weaken the FDA – We Asked Why
FDA
right-to-try laws
Senate
Senator Ron Johnson
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'Patient-focused' drug development guidance coming, FDA chief says
'Patient-focused' drug development guidance coming, FDA chief says
Biopharma Dive
FDA
patients
drug development
Scott Gottlieb
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Sage to Expedite Development of SAGE-217 in Major Depressive Disorder and Postpartum Depression
Sage to Expedite Development of SAGE-217 in Major Depressive Disorder and Postpartum Depression
CP Wire
SAGE Therapeutics
FDA
breakthrough status
SAGE-217
major depressive disorder
postpartum depression
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VA looks to launch largest US medical implant registry
VA looks to launch largest US medical implant registry
Mass Device
Veterans Administration
FDA
Department of Defense
devices
implants
implant registry
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Ironwood Pharma’s Sickle Cell Drug Gets Orphan Drug Designation
Ironwood Pharma’s Sickle Cell Drug Gets Orphan Drug Designation
BioSpace
Ironwood Pharmaceuticals
FDA
sickle cell disease
olinciguat
orphan drug
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Gottlieb at BIO: FDA developing processes around right-to-try law
Gottlieb at BIO: FDA developing processes around right-to-try law
Med City News
FDA
Scott Gottlieb
right-to-try laws
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