FDA

Y-mAbs ramps up head count in post-IPO hiring spree
Y-mAbs ramps up head count in post-IPO hiring spree
Fierce Biotech
Y-mAbs
IPO
FDA
hirings
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Roche scores double cancer approval for new Bayer rival Rozlytrek
Roche scores double cancer approval for new Bayer rival Rozlytrek
Fierce Pharma
Roche
Rozlytrek
FDA
NTRK fusion-positive tumors
non-small cell lung cancer
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The real-world evidence project at the FDA adds Syapse to its list of partners in a push past trial boundaries
The real-world evidence project at the FDA adds Syapse to its list of partners in a push past trial boundaries
Endpoints
FDA
Syapse
EHRs
clinical trials
RWE
real world evidence
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Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA
Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA
Fierce Pharma
FDA
Dr Reddy's
Copaxone
Teva Pharmaceutical
generics
Merck
Nuvaring
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FDA approves TB pill that cures more hard-to-treat patients
FDA approves TB pill that cures more hard-to-treat patients
Stat
FDA
tuberculosis
Pretomanid
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AveXis scientific founder is out as Novartis names a new CSO in wake of an ethics scandal
AveXis scientific founder is out as Novartis names a new CSO in wake of an ethics scandal
Endpoints
Novartis
AveXis
Zolgensma
FDA
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Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation
Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation
Fierce Pharma
Novartis
FDA
Zolgensma
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10 Events in Medtech That We Didn’t See Coming This Year
10 Events in Medtech That We Didn’t See Coming This Year
Medical Devices and Diagnostics Industry
devices
Edwards Lifesciences
Boston Scientific
Thrive Earlier Detection
Obalon
Alcon
Abbott Labs
Theranos
JNJ
robotic surgery
Becton Dickinson
FDA
sterlization
Scott Gottlieb
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FDA to Drug Manufacturers: Outdated Listings Will be Inactivated
FDA to Drug Manufacturers: Outdated Listings Will be Inactivated
RAPS.org
FDA
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5 Biggest New Drugs Approved in 2019 So Far
5 Biggest New Drugs Approved in 2019 So Far
Motley Fool
drug approvals
FDA
AbbVie
JNJ
Novartis
Pfizer
Skyrizi
psoriasis
Vyndaqel
Zolgensma
SMA
Mayzent
multiple sclerosis
Balversa
metastatic bladder cancer
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Questions pile up for Novartis as senators call on FDA to take action
Questions pile up for Novartis as senators call on FDA to take action
Endpoints
Novartis
FDA
Senate
Zolgensma
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Regeneron gets FDA approval for Eylea injection prefilled syringe
Regeneron gets FDA approval for Eylea injection prefilled syringe
Ophthalmology Times
Regeneron
Eylea
FDA
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Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity
Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity
RAPS.org
FDA
clinical trials
diversity
real world data
real world evidence
RWE
RWD
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Questions Pile up for Novartis as Senators Call on FDA to Take Action
Questions Pile up for Novartis as Senators Call on FDA to Take Action
RAPS.org
FDA
Novartis
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5 Reasons Novartis Shareholders Aren't Shaken
5 Reasons Novartis Shareholders Aren't Shaken
Yahoo/Motley Fool
Novartis
Zolgensma
FDA
shareholders
Entresto
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GAO Pushes FDA to Improve First Cycle Generic Approval Rate
GAO Pushes FDA to Improve First Cycle Generic Approval Rate
RAPS.org
GAO
drug approvals
FDA
generics
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FDA wants additional data on Kala Pharma’s KPI-121
FDA wants additional data on Kala Pharma’s KPI-121
Pharma Letter
Kala Pharmaceuticals
KP-121
dry eye disease
FDA
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DBV Technologies Resubmits BLA for Peanut Allergy Treatment
DBV Technologies Resubmits BLA for Peanut Allergy Treatment
BioSpace
DBV Technologies
FDA
peanut allergy
Viaskin Peanut
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Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting
Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting
Fierce Pharma
Amarin
Vascepa
advisory panels
FDA
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Vesselon acquires FDA-approved Lipid Microsphere Drug Imagent for therapeutic platform
Vesselon acquires FDA-approved Lipid Microsphere Drug Imagent for therapeutic platform
Pharmaceutical Business Review
Vesselon
oncology
FDA
Imagent
liquid microspherePH
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