FDA

Price-hike king Valeant could be hit hardest by FDA generics push: analyst
Price-hike king Valeant could be hit hardest by FDA generics push: analyst
Fierce Pharma
Valeant Pharmaceuticals
FDA
generics
drug pricing
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FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition
FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition
RAPS.org
FDA
generics
competition
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US Senate’s FDA User Fee Reauthorization Bill Advances, without $1 Billion Increase Proposed by Trump
US Senate’s FDA User Fee Reauthorization Bill Advances, without $1 Billion Increase Proposed by Trump
Emergo
FDA
Senate
user fees
Donald Trump
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The FDA may move to shorten that grim list of side effects on every drug ad. Advertising execs can’t wait
The FDA may move to shorten that grim list of side effects on every drug ad. Advertising execs can’t wait
Stat
drug ads
DTC advertising
side effects
FDA
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FDA Rejects Pfizer's Anemia Drug Biosimilar
FDA Rejects Pfizer's Anemia Drug Biosimilar
Xtalks
FDA
Pfizer
biosimilars
Epogen
Amgen
anemia
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FDA guidance explains electronic records for medical device clinical trials
FDA guidance explains electronic records for medical device clinical trials
Mass Device
FDA
devices
clinical trials
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With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition
With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition
Fierce Pharma
patents
Takeda
Velcade
FDA
exclusivity
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The FDA Has Never Approved a Drug Like This in Its 111-Year History
The FDA Has Never Approved a Drug Like This in Its 111-Year History
Motley Fool
FDA
Merck
Keytruda
mismatch repair deficiency
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Portola Pharmaceuticals' FDA Nod Could Spark M&A Interest
Portola Pharmaceuticals' FDA Nod Could Spark M&A Interest
Motley Fool
Portola Pharmaceuticals
FDA
M&A
Bevyxxa
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Portola Pharmaceuticals’ Drug to Prevent Blood Clots Wins FDA Nod
Portola Pharmaceuticals’ Drug to Prevent Blood Clots Wins FDA Nod
Xconomy
Portola Pharmaceuticals
blood clots
FDA
Bevyxxa
betrixaban
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FDA approves diagnostic that simultaneously screens for multiple cancer biomarkers
FDA approves diagnostic that simultaneously screens for multiple cancer biomarkers
Drug Delivery Business News
FDA
Thermofisher
diagnostics
biomarkers
non-small cell lung cancer
Oncomine Dx Target Test
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Novartis picks up FDA approval for targeted lung cancer meds Tafinlar, Mekinist
Novartis picks up FDA approval for targeted lung cancer meds Tafinlar, Mekinist
Fierce Pharma
Novartis
FDA
Tafinlar
Mekinist
non-small cell lung cancer
BRAF V600
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FDA says yes to rapid-acting Rituxan
FDA says yes to rapid-acting Rituxan
BioPharma Dive
FDA
Roche
Rituxan Hycela
refractory follicular lymphoma
CLL
diffuse large B-cell lymphoma
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FDA rejects Pfizer's Epogen biosimilar for the second time
FDA rejects Pfizer's Epogen biosimilar for the second time
Fierce Pharma
FDA
Pfizer
biosimilars
Epogen
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FDA OKs CSL’s new HAE drug, already embroiled in a blockbuster fight with Shire
FDA OKs CSL’s new HAE drug, already embroiled in a blockbuster fight with Shire
Endpoints
FDA
CSL
HAE
hereditary angiodema
Shire
Haegarda
Firazyr
Kalbito
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FDA padlocks any new human tests on Seattle Genetics’ cancer drug in the wake of more deaths
FDA padlocks any new human tests on Seattle Genetics’ cancer drug in the wake of more deaths
Endpoints
FDA
Seattle Genetics
clinical trials
vadastuximab talirine
AML
acute myeloid leukemia
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FDA Science: Working at the speed of emerging technologies
FDA Science: Working at the speed of emerging technologies
Mass Device
FDA
technology
Luciana Borio
R&D
innovation
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A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access
A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access
FDA Law Blog
FDA
innovation
drug access
Hatch Waxman Act
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FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes
FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes
Bloomberg
FDA
gene therapy
tumor-agnostic therapies
cancer
Scott Gottlieb
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FDA issued 47 Product Recalls, Import Alerts, and Consent Decrees in May 2017
FDA issued 47 Product Recalls, Import Alerts, and Consent Decrees in May 2017
FDAzilla
FDA
recalls
consent decree
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