FDA

2 NASH drugmakers have wildly different Mondays
2 NASH drugmakers have wildly different Mondays
Biopharma Dive
Intercept Pharmaceuticals
CymaBay Therapeutics
FDA
NASH
seladelpar
obeticholic acid
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FDA rejects Adamis opioid overdose therapy Zimhi, hitting share price
FDA rejects Adamis opioid overdose therapy Zimhi, hitting share price
Pharmaforum
Adamis Pharmaceuticals
FDA
Zimhi
opioids
opioid overdose
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SK Biopharmaceuticals, fresh off an FDA nod, preps for $850M IPO in January: report
SK Biopharmaceuticals, fresh off an FDA nod, preps for $850M IPO in January: report
Fierce Pharma
SK Biopharmaceuticals
South Korea
FDA
Xcopri
IPOs
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AstraZeneca's Calquence Wins FDA Approval for Chronic Lymphocytic Leukemia
AstraZeneca's Calquence Wins FDA Approval for Chronic Lymphocytic Leukemia
BioSpace
AstraZeneca
FDA
CLL
SLL
Calquence
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FDA releases 81 product-specific guidances
FDA releases 81 product-specific guidances
Endpoints
FDA
generics
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Elsevier gets FDA backing for ‘predictive toxicology’ project
Elsevier gets FDA backing for ‘predictive toxicology’ project
Pharmaforum
Elsevier
FDA
drug development
predictive toxicology
liver toxicity
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Epilepsy's new company on the block wins FDA approval for made-in-Korea drug to treat focal seizures
Epilepsy's new company on the block wins FDA approval for made-in-Korea drug to treat focal seizures
Endpoints
FDA
Korea
partial onset seizures
SK Life Science
Xcopri
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Biogen’s top scientist nearly dares FDA not to approve Alzheimer’s drug
Biogen’s top scientist nearly dares FDA not to approve Alzheimer’s drug
Stat
Biogen
aducanumab
FDA
Alzheimer's disease
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After 18 Years, FDA Approves Malaria Prevention Drug
After 18 Years, FDA Approves Malaria Prevention Drug
Xtalks
Sixty Degrees Pharma
antimalarial
maleria
FDA
Arakoda
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FDA Commissioner nominee Hahn promises to put science above politics
FDA Commissioner nominee Hahn promises to put science above politics
Fierce Pharma
FDA
Stephen Hahn
political
regulatory
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FDA's rapid review pace nets an early approval for Alnylam's second drug
FDA's rapid review pace nets an early approval for Alnylam's second drug
Biopharma Dive
FDA
Alnylam
Givlaari
givosiran
RNAi
porphyria
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Allergan builds case for migraine drug ubrogepant as FDA verdict nears
Allergan builds case for migraine drug ubrogepant as FDA verdict nears
Pharmaforum
Allergan
migraines
ubrogepant
FDA
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If Biosimilars Are Struggling, Someone Forgot to Tell Coherus BioSciences
If Biosimilars Are Struggling, Someone Forgot to Tell Coherus BioSciences
Motley Fool
biosimilars
FDA
Coherus Biosciences
Neulasta
Amgen
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FDA Approves Contact that Slows Nearsightedness Progression
FDA Approves Contact that Slows Nearsightedness Progression
RAPS.org
CooperVision
contact lens
pediatric
myopia
devices
FDA
MiSight lenses
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FDA approves latest Humira near-copy, as dozens of biosimilars head for market
FDA approves latest Humira near-copy, as dozens of biosimilars head for market
Pharmaforum
FDA
Pfizer
biosimilars
Humira
AbbVie
Abrilada
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AHA: Amarin's Vascepa halts progression of arterial plaque in key study
AHA: Amarin's Vascepa halts progression of arterial plaque in key study
Fierce Pharma
Amarin
Vascepa
AHA
FDA
aterial plaque
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FDA Approves Crizanlizumab: Here Is A New Drug For Sickle Cell Disease
FDA Approves Crizanlizumab: Here Is A New Drug For Sickle Cell Disease
Forbes
Novartis
Adakveo
FDA
crizanlizumab
sickle cell disease
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FDA Approves Talicia To Treat Superbug Linked To Stomach Cancer
FDA Approves Talicia To Treat Superbug Linked To Stomach Cancer
Forbes
superbugs
antibiotics
antibiotic resistance
Talicia
FDA
stomach bug
Helicobecter pylori
Redhill Biopharma
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FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports
FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports
RAPS.org
FDA
regulatory
annual reports
NDAs
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Novartis sickle-cell drug wins FDA approval
Novartis sickle-cell drug wins FDA approval
Biopharma Dive
FDA
Novartis
Adakveo
sickle cell disease
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