FDA

The FDA Just Approved a New Pfizer Cancer Drug for a Rare, Vicious Leukemia
The FDA Just Approved a New Pfizer Cancer Drug for a Rare, Vicious Leukemia
Yahoo/Fortune
FDA
Pfizer
Besponsa
acute lymphoblastic leukemia
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Watch out Tesaro, AstraZeneca and Merck get FDA OK for broad use of Lynparza
Watch out Tesaro, AstraZeneca and Merck get FDA OK for broad use of Lynparza
Endpoints
Tesaro
AstraZeneca
Merck
FDA
Lynparza
Zejula
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Surprise: A short list of TV-ad drug risks is easier to recall, FDA study finds
Surprise: A short list of TV-ad drug risks is easier to recall, FDA study finds
Fierce Pharma
drug ads
television ads
FDA
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FDA Warning Letters: First Half of 2017 Trends
FDA Warning Letters: First Half of 2017 Trends
AssuRx
FDA
warnings
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New study of FDA cites the flaws behind rapid-fire cancer drug OKs
New study of FDA cites the flaws behind rapid-fire cancer drug OKs
Endpoints
FDA
drug approvals
cancer
oncology
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Take two: Portola's reversal agent secures FDA review
Take two: Portola's reversal agent secures FDA review
BioPharma Dive
Portola Pharmaceuticals
FDA
AndexXa
anticoagulant reversal
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FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision
FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision
FDA Law Blog
FDA
Xtampza ER
Hatch Waxman Act
exclusivity
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With an eye on the FDA, Lexicon and Sanofi line up more positive data on diabetes drug
With an eye on the FDA, Lexicon and Sanofi line up more positive data on diabetes drug
Endpoints
FDA
Lexicon Pharmaceuticals
Sanofi
type 1 diabetes
sotagliflozin
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FDA gives OK, Cel-Sci clinical hold finally lifted
FDA gives OK, Cel-Sci clinical hold finally lifted
BioPharma Dive
FDA
Cell-Sci
Multikine
clinical trials
head and neck cancer
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FDA puts new restrictions on hiring of foreign scientists, documents show
FDA puts new restrictions on hiring of foreign scientists, documents show
Stat
FDA
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FDA Considers WHO Scheduling Change for 17 Drug Substances
FDA Considers WHO Scheduling Change for 17 Drug Substances
RAPS.org
WHO
FDA
opioids
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Gilead circles February 12 on its calendar as D-day for its HIV franchise
Gilead circles February 12 on its calendar as D-day for its HIV franchise
Endpoints
Gilead Sciences
HIV
FTC/TAF
FDA
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Mylan points finger at FDA for failure to win nods on Advair, Copaxone copies
Mylan points finger at FDA for failure to win nods on Advair, Copaxone copies
Fierce Pharma
Mylan Labs
FDA
Advair
Copaxone
generics
Teva Pharmaceutical
GSK
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Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
RAPS.org
drug approvals
FDA
priority review
accelerated approvals
fast track
breakthrough status
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Spurred by Gottlieb, FDA on track to the most generic drug OKs ever in 1 year
Spurred by Gottlieb, FDA on track to the most generic drug OKs ever in 1 year
Endpoints
FDA
generics
Scott Gottlieb
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Prepping for a rapid-fire launch, Kite Pharma gets a pass from FDA on axi-cel panel review
Prepping for a rapid-fire launch, Kite Pharma gets a pass from FDA on axi-cel panel review
Endpoints
Kite Pharma
FDA
drug launches
axi-cel
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FDA approves Jazz Pharmaceuticals’ liposomal AML chemotherapy
FDA approves Jazz Pharmaceuticals’ liposomal AML chemotherapy
Drug Delivery Business News
FDA
Jazz Pharmaceuticals
liposomal chemotherapy
Vyxeos
AML
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FDA's generic competition push hits Valeant's Isuprel, a price-hike poster child
FDA's generic competition push hits Valeant's Isuprel, a price-hike poster child
Fierce Pharma
FDA
generics
Valeant Pharmaceuticals
Isuprel
drug pricing
nexus
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FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads
FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads
RAPS.org
FDA
television ads
risk info
side effects
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FDA approves 4-year intrauterine device
FDA approves 4-year intrauterine device
Drug Delivery Business News
FDA
Allergan
IUD
devices
contraceptives
Liletta
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