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FDA
US FDA sheds light on medical device advisory panels
Mass Device
Wed, 04/1/15 - 11:15 am
FDA
devices
advisory panels
Is the FDA Worried About Vertex's New Drug?
Investopedia
Tue, 03/31/15 - 05:54 pm
FDA
Vertex Pharmaceuticals
Kalydeco
lumacaftor
cystic fibrosis
Dyax shares jump on drug study, FDA fast-track status
Marketwatch
Tue, 03/31/15 - 05:53 pm
Dyax
FDA
fast track
DX-2930
hereditary angiodema
FDA 'Taking a Very Light Touch' on Regulating the Apple Watch
Yahoo/Bloomberg
Mon, 03/30/15 - 10:58 am
FDA
devices
Apple
iWatch
In swan song, FDA chief Hamburg defends approval process
Mass Device
Mon, 03/30/15 - 09:55 am
FDA
Margaret Hamburg
drug approvals
FDA rejects Adamis Pharma's injection for treating allergic reactions
Yahoo/Reuters
Sat, 03/28/15 - 10:41 am
FDA
Adamis Pharmaceuticals
epinephrine
Eisai gets EMA nod for Lenvima just weeks after FDA approval
Fierce Pharma
Fri, 03/27/15 - 09:35 pm
Eisai
FDA
Lenvima
thyroid cancer
Denied Again! Another Obstacle to Biosimilar First Launch Falls with FDA Rejection of Amgen’s Certification Petition
FDA Law Blog
Fri, 03/27/15 - 08:39 am
Amgen
biosimilars
FDA
Sandoz
Neupogen
Zarxio
FDA is Sued by Otsuka for ‘Unlawfully’ Widening the Market for Abilify
WSJ Pharmalot
Thu, 03/26/15 - 09:30 pm
FDA
Otsuka
Abilify
antipsychotics
generics
Wright Medical wins FDA nod for Salvation external fixation device
Mass Device
Thu, 03/26/15 - 09:36 am
Wright Medical
FDA
Salvation external fixation
foot and ankle
devices
FDA again expands usage of Regeneron eye drug Eylea
Yahoo/Reuters
Thu, 03/26/15 - 07:49 am
Eylea
Regeneron
FDA
FDA Scolds Another Indian Drug Maker for Quality Control Problems
WSJ Pharmalot
Thu, 03/26/15 - 07:35 am
FDA
India
drug manufacturing
Aarti Drugs
FDA's rare disease pediatric voucher program could become permanent
BioPharma Dive
Wed, 03/25/15 - 03:09 pm
FDA
Rare Diseases
pediatrics
FDA approves Emergent BioSolutions' anthrax treatment
Yahoo/Reuters
Wed, 03/25/15 - 10:20 am
FDA
Emergent BioSolutions
anthrax
Anthrasil
FDA Grants Premarket Approval To AbioMed Heart Pump
Forbes
Tue, 03/24/15 - 11:11 am
FDA
devices
Abiomed
Impella 2.5
heart pump
One, Two, Three . . . and They’re Out! FDA Issues Third Rare Pediatric Disease Priority Review Voucher, Triggering One-Year Sunset Clause
FDA Law Blog
Tue, 03/24/15 - 10:15 am
FDA
pediatrics
Cholbam
Faster FDA Spurs Cancer Breakthroughs
Yahoo/Bloomberg
Tue, 03/24/15 - 08:46 am
FDA
canccer
R&D
drug approvals
FDA recommends no changes to Lilly's schizophrenia injection use
Yahoo/Reuters
Tue, 03/24/15 - 08:26 am
FDA
Eli Lilly
schizophrenia
Zyprexa Relprevv
The Single Worst Practice of Medical Device Makers
Motley Fool
Mon, 03/23/15 - 09:12 am
devices
JNJ
FDA
pre-market testing
GSK And Theravance: Implications Of The Advisory Panel Decision
Seeking Alpha
Sun, 03/22/15 - 10:52 am
GSK
Theravance
FDA
advisory panels
Breo Ellipta
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