breakthrough therapy

Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly's arrival
Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly's arrival
Fierce Biotech
Concert Pharmaceuticals
alopecia areata
FDA
breakthrough therapy
deuruxolitinib
Eli Lilly
olumiant
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Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
BioSpace
Moderna Therapeutics
FDA
mRNA-1345
vaccines
RSV
breakthrough therapy
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Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
Drugs.com
Pfizer
elranatamab
FDA
breakthrough therapy
relapsed or refractory multiple myeloma
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Janssen secures FDA breakthrough designation for myeloma therapy
Janssen secures FDA breakthrough designation for myeloma therapy
Pharmaceutical Business Review
JNJ
Janssen
breakthrough therapy
FDA
talquetamab
Multiple Myeloma
relapsed or refractory multiple myeloma
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Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up
Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up
BioSpace
Roche
FDA
breakthrough therapy
Alzheimer's disease
gantenerumab
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Roche's Gantenerumab Gets FDA Breakthrough Therapy Designation for Alzheimer's Disease
Roche's Gantenerumab Gets FDA Breakthrough Therapy Designation for Alzheimer's Disease
Marketwatch
Roche
FDA
gantenerumab
Alzheimer's disease
breakthrough therapy
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How AbbVie Could Make an Entry Into This Rapidly Growing Drug Market
How AbbVie Could Make an Entry Into This Rapidly Growing Drug Market
Motley Fool
AbbVie
Roche
Venclexta
MDS
breakthrough therapy
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Pneumococcal Vaccine Snags Breakthrough Therapy Designation
Pneumococcal Vaccine Snags Breakthrough Therapy Designation
BioSpace
Astellas
Affinivax
vaccines
pneumococcal disease
breakthrough therapy
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Novartis sets the tone for the radiopharma push with a prized acquisition winning breakthrough therapy designation
Novartis sets the tone for the radiopharma push with a prized acquisition winning breakthrough therapy designation
Endpoints
Novartis
radiopharmaceuticals
breakthrough therapy
FDA
Lu-PSMA-617
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Immunocore gets FDA breakthrough nod for eye melanoma drug ahead of planned Q3 filing
Immunocore gets FDA breakthrough nod for eye melanoma drug ahead of planned Q3 filing
Fierce Biotech
Immunocore
FDA
uveal melanoma
breakthrough therapy
tebentafusp
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Novartis gets FDA breakthrough therapy status for ligelizumab to treat chronic spontaneous urticaria
Novartis gets FDA breakthrough therapy status for ligelizumab to treat chronic spontaneous urticaria
Pharmaceutical Business Review
Novartis
breakthrough therapy
FDA
ligelizumab
chronic spontaneous urticaria
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Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow
Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow
Endpoints
Novo Nordisk
earnings
NASH
semaglutide
breakthrough therapy
FDA
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The FDA hands Farxiga 'breakthrough' status in CKD, clearing path for AstraZeneca's much-touted therapy
The FDA hands Farxiga 'breakthrough' status in CKD, clearing path for AstraZeneca's much-touted therapy
Endpoints
AstraZeneca
chronic kidney disease
FDA
breakthrough therapy
Farxiga
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Gilead gets FDA breakthrough therapy status for magrolimab in MDS
Gilead gets FDA breakthrough therapy status for magrolimab in MDS
Pharmaceutical Business Review
Gilead Sciences
FDA
MDS
magrolimab
breakthrough therapy
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AstraZeneca, Daiichi Sankyo get FDA breakthrough therapy status for gastric cancer drug
AstraZeneca, Daiichi Sankyo get FDA breakthrough therapy status for gastric cancer drug
Pharmaceutical Business Review
AstraZeneca
Daiichi Sankyo
FDA
Enhertu
gastric cancer
breakthrough therapy
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Acceleron's PAH drug gets the FDA's red carpet treatment with breakthrough status
Acceleron's PAH drug gets the FDA's red carpet treatment with breakthrough status
Endpoints
Acceleron
PAH
FDA
breakthrough therapy
sotatercept
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Lilly, Incyte get FDA breakthrough therapy status for baricitinib to treat alopecia areata
Lilly, Incyte get FDA breakthrough therapy status for baricitinib to treat alopecia areata
Pharmaceutical Business Review
Eli Lilly
Incyte
breakthrough therapy
FDA
baricitinib
alopecia areata
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J&J’s Experimental Lung Cancer Drug Receives Breakthrough Therapy Designation
J&J’s Experimental Lung Cancer Drug Receives Breakthrough Therapy Designation
BioSpace
Janssen
JNJ
FDA
JNJ-6372
breakthrough therapy
metastatic non-small cell lung cancer
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Genentech's Esbriet Granted Breakthrough Therapy Designation for uILD
Genentech's Esbriet Granted Breakthrough Therapy Designation for uILD
BioSpace
Genentech
Esbriet
uILD
breakthrough therapy
FDA
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Failed pivotal study? You can still have breakthrough therapy status — FDA signals to Resverlogix
Failed pivotal study? You can still have breakthrough therapy status — FDA signals to Resverlogix
Endpoints
Resverlogix
breakthrough therapy
clinical trials
FDA
apabetalone
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