breakthrough status

Pfizer revs up to leave GSK in the dust as maternal RSV vax granted FDA breakthrough tag
Pfizer revs up to leave GSK in the dust as maternal RSV vax granted FDA breakthrough tag
Fierce Biotech
Pfizer
GSK
vaccines
RSV
PF-06482077
FDA
breakthrough status
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Boehringer secures FDA’s Breakthrough Therapy Designation for oral therapy
Boehringer secures FDA’s Breakthrough Therapy Designation for oral therapy
Pharmaceutical Business Review
Boehringer Ingelheim
idiopathic pulmonary fibrosis
FDA
BI 1015550
breakthrough status
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Eisai-Biogen Alzheimer’s drug gets FDA breakthrough designation
Eisai-Biogen Alzheimer’s drug gets FDA breakthrough designation
Pharmaceutical Business Review
Eisai
Biogen
FDA
lecanemab
breakthrough status
Alzheimer's disease
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Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer
Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer
Endpoints
AstraZeneca
Daiichi Sankyo
Enhertu
breakthrough status
FDA
metastatic gastric cancer
gastric cancer
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Riding a PhII success, a small French biotech lands a rare 'breakthrough' status in NASH
Riding a PhII success, a small French biotech lands a rare 'breakthrough' status in NASH
Endpoints
Inventiva
NASH
France
FDA
breakthrough status
lanifibranor
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Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis
Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis
Pharmaceutical Business Review
Sanofi
Regeneron
Dupixent
FDA
eosinophilic esophagitis
breakthrough status
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Takeda gets FDA breakthrough therapy status for pevonedistat to treat higher-risk HR-MDS
Takeda gets FDA breakthrough therapy status for pevonedistat to treat higher-risk HR-MDS
Pharmaceutical Business Review
Takeda Pharmaceuticals
breakthrough status
FDA
pevonedistat
myelodysplastic syndrome
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Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD
Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD
Pharmaceutical Business Review
Bristol-Myers Squibb
Orencia
graft vs host disease
FDA
breakthrough status
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7 Reasons for Medtech to Be Thankful in 2019
7 Reasons for Medtech to Be Thankful in 2019
Medical Devices and Diagnostics Industry
devices
FDA
robotic surgery
breakthrough status
Medtronic
Abbott Labs
artificial intelligence
paclitaxel
3D printing
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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
devices
FDA
breakthrough status
Active Implants
NUsurface
meniscus surgery
artificial meniscus
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PhaseBio touts 'breakthrough' badge for bloodthinner reversal agent licensed from AstraZeneca, shares leap
PhaseBio touts 'breakthrough' badge for bloodthinner reversal agent licensed from AstraZeneca, shares leap
Endpoints
PhaseBio
Brilinta
PB2452
bloodthinner reversals
breakthrough status
AstraZeneca
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When Biotechs Get Breakthrough Therapy Status, Mr. Market Yawns
When Biotechs Get Breakthrough Therapy Status, Mr. Market Yawns
Forbes
breakthrough status
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FDA blesses Merck’s PhIII effort to topple a mega-blockbuster — but there’s also a little biotech in this game
FDA blesses Merck’s PhIII effort to topple a mega-blockbuster — but there’s also a little biotech in this game
Endpoints
Merck
V114
vaccines
FDA
breakthrough status
Prevnar 13
Pfizer
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FDA grants breakthrough status to joint Merck-Bayer AI program
FDA grants breakthrough status to joint Merck-Bayer AI program
Mass Device
Merck
Bayer
FDA
breakthrough status
devices
CTEPH
artificial intelligence
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FDA waves Loxo through for second ‘breakthrough’ in tissue-agnostic cancer therapy
FDA waves Loxo through for second ‘breakthrough’ in tissue-agnostic cancer therapy
Endpoints
Loxo Oncology
FDA
breakthrough status
LOXO-292
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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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Gottlieb pushes back against criticism of ‘breakthrough’ designation
Gottlieb pushes back against criticism of ‘breakthrough’ designation
Stat
FDA
breakthrough status
Scott Gottlieb
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FDA Grants Breakthrough Therapy Status to Pfizer's Trumenba for Prevention of Meningococcal B Disease in Children
FDA Grants Breakthrough Therapy Status to Pfizer's Trumenba for Prevention of Meningococcal B Disease in Children
CP Wire
Pfizer
Trumenba
vaccines
meningococcal B
FDA
breakthrough status
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Roche gets double dose of good Hemlibra news with FDA breakthrough, ICER backing
Roche gets double dose of good Hemlibra news with FDA breakthrough, ICER backing
Fierce Pharma
Roche
Hemlibra
hemophilia
FDA
breakthrough status
ICER
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Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes
Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes
Endpoints
FDA
Harvard
breakthrough status
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