FDA

Seattle Genetics, Astellas snag quick FDA approval for bladder cancer-fighter Padcev
Seattle Genetics, Astellas snag quick FDA approval for bladder cancer-fighter Padcev
Fierce Pharma
Seattle Genetics
Astellas
FDA
Padcev
metastatic bladder cancer
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Merck’s Keytruda nabs FDA panel's favor to line up for new bladder cancer OK
Merck’s Keytruda nabs FDA panel's favor to line up for new bladder cancer OK
Fierce Pharma
Merck
Keytruda
FDA
bladder cancer
NMIBC
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FDA takes another step to encourage copycat insulin products
FDA takes another step to encourage copycat insulin products
Pharmaforum
FDA
diabetes
insulin
biosimilars
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FDA survey finds Americans don’t really understand drug approvals
FDA survey finds Americans don’t really understand drug approvals
Endpoints
FDA
drug approvals
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AZ, Merck's Lynparza narrowly snags FDA panel backing in pancreatic cancer
AZ, Merck's Lynparza narrowly snags FDA panel backing in pancreatic cancer
Fierce Pharma
AstraZeneca
Merck
Lynparza
pancreatic cancer
FDA
advisory panels
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The FTC moves to block DNA sequencer Illumina’s acquisition of PacBio, calling company a ‘monopolist’
The FTC moves to block DNA sequencer Illumina’s acquisition of PacBio, calling company a ‘monopolist’
Stat
FDA
DNA sequencing
Illumina
Pacific Biosciences
M&A
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PharmaMar files for FDA approval of small cell lung cancer drug
PharmaMar files for FDA approval of small cell lung cancer drug
Fierce Biotech
PharmaMar
FDA
lurbinectedin
small cell lung cancer
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FDA Wants to End Quarterly Reporting of Device Decisions
FDA Wants to End Quarterly Reporting of Device Decisions
RAPS.org
FDA
devices
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FDA’s in-house review offers bleak assessment of Epizyme’s tazemetostat — but win or lose this cancer drug may still have a future
FDA’s in-house review offers bleak assessment of Epizyme’s tazemetostat — but win or lose this cancer drug may still have a future
Endpoints
Epizyme
FDA
tazemetostat
epithelioid sarcoma
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Pfizer, Astellas' Xtandi matches J&J's rival Erleada with new prostate cancer nod
Pfizer, Astellas' Xtandi matches J&J's rival Erleada with new prostate cancer nod
Fierce Pharma
Pfizer
Astellas
Xtandi
prostate cancer
JNJ
Erleada
FDA
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Deciphera files for approval of cancer drug ahead of schedule
Deciphera files for approval of cancer drug ahead of schedule
Fierce Biotech
Deciphera
ripretinib
gastrointestinal stromal tumors
FDA
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Is AZ, Merck's Lynparza approvable in pancreatic cancer sans survival benefit? FDA's about to decide
Is AZ, Merck's Lynparza approvable in pancreatic cancer sans survival benefit? FDA's about to decide
Fierce Pharma
AstraZeneca
Merck
Lynparza
FDA
BRCA-mutated pancreatic cancer
pancreatic cancer
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Sun says Halol plant cited again by the FDA
Sun says Halol plant cited again by the FDA
Fierce Pharma
FDA
drug manufacturing
Sun Pharma
India
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Boston Scientific Wins FDA Clearance for the World's First Fully Disposable Duodenoscope
Boston Scientific Wins FDA Clearance for the World's First Fully Disposable Duodenoscope
Medical Devices and Diagnostics Industry
devices
Boston Scientific
FDA
duodenoscope
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Intercept's NASH decision delayed by FDA, but don't panic: analysts
Intercept's NASH decision delayed by FDA, but don't panic: analysts
Fierce Pharma
Intercept Pharmaceuticals
NASH
obeticholic acid
FDA
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The Week Ahead In Biotech: Avadel, Epizyme In Focus In A Quiet Week
The Week Ahead In Biotech: Avadel, Epizyme In Focus In A Quiet Week
Yahoo/Benzinga
Epizyme
tazemetostat
Avadel
AV001
FDA
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Amarin stock heads toward highest prices in more than a decade after new Vascepa FDA approval
Amarin stock heads toward highest prices in more than a decade after new Vascepa FDA approval
Yahoo/Marketwatch
Amarin
Vascepa
FDA
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Amarin eyes blockbuster Vascepa sales as FDA grants heart-helping label expansion
Amarin eyes blockbuster Vascepa sales as FDA grants heart-helping label expansion
Fierce Pharma
Amarin
Vascepa
FDA
Cardiovascular
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FDA expert panel unanimously recommends approval for Horizon Therapeutics eye drug
FDA expert panel unanimously recommends approval for Horizon Therapeutics eye drug
Endpoints
FDA
advisory panels
Horizon Therapeutics
thyroid eye disease
teprotumumab
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FDA Finalizes Rule to Go From Paper to Electronic Device Submissions
FDA Finalizes Rule to Go From Paper to Electronic Device Submissions
RAPS.org
FDA
devices
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