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FDA
US FDA: 17 Medical devices accepted into expedited access program so far
Mass Device
Mon, 06/6/16 - 11:02 am
devices
FDA
Expedited Access Pathway
Teva's opioid not abuse-deterrent when taken orally -FDA staff
Yahoo/Reuters
Fri, 06/3/16 - 09:53 pm
Teva Pharmaceuticals
opioids
abuse-resistant painkillers
FDA
Vantrela
FDA’s Woodcock: ‘No connection’ between new drug access policy, Sarepta drug decision
Bizjournals.com
Fri, 06/3/16 - 09:52 pm
FDA
Sarepta Therapeutics
Janet Woodcock
Duchenne Muscular Dystrophy
eteplirsen
FDA looks to speed compassionate use applications
Mass Device
Thu, 06/2/16 - 10:42 pm
FDA
compassionate use guidelines
Sarepta sinks as FDA changes drug approval rules
CNBC
Thu, 06/2/16 - 04:08 pm
Sarepta Therapeutics
FDA
drug approvals
eteplirsen
Duchenne Muscular Dystrophy
Science, not public opinion, should rule FDA drug approvals
Stat
Thu, 06/2/16 - 04:02 pm
FDA
science
drug approvals
public opinion
patients
House panel look to ease FDA’s curbs on off-label marketing
Mass Device
Thu, 06/2/16 - 10:02 am
FDA
off-label
devices
2 FDA Decisions To Watch In June
Seeking Alpha
Wed, 06/1/16 - 10:54 am
FDA
rociletinib
Clovis Oncology
KemPharm
Apadaz
Blame the FDA for missing-in-action off-label guidelines? Nope, say two lawmakers. It's the HHS
Fierce Pharma
Tue, 05/31/16 - 10:15 pm
FDA
off-label
free speech
HHS
FDA asks Teva Pharmaceutical for further study on Huntington drug
Yahoo/Reuters
Tue, 05/31/16 - 10:07 am
Teva Pharmaceutical
FDA
Huntington's disease
SD-809
chorea
Intercept Wins FDA Approval for Drug to Treat Liver Disease
Bloomberg
Mon, 05/30/16 - 10:08 am
Intercept Pharma
FDA
Ocaliva
obeticholic acid
primary biliary cirrhosis
Biogen, AbbVie once-monthly MS injection wins U.S. approval
Yahoo/Reuters
Fri, 05/27/16 - 11:03 pm
Biogen
AbbVie
MS
multiple sclerosis
FDA
Zinbryta
Delayed FDA Decision Sends Sarepta Therapeutics Soaring
Yahoo/Market Realist
Fri, 05/27/16 - 12:47 pm
Sarepta Therapeutics
DMD
FDA
eteplirsen
AstraZeneca Remains Committed To Development Of ZS-9 Despite Letter From FDA
Yahoo/Benzinga
Fri, 05/27/16 - 12:42 pm
AstraZeneca
FDA
ZS-9
hyperkalaemia
ZS Pharma
Cancer Drugs Are The Least Likely to Receive FDA Approval
Fortune
Thu, 05/26/16 - 10:51 pm
FDA
drug approvals
cancer
First Implant to Treat Opioid Addiction Gets FDA Approval
Bloomberg
Thu, 05/26/16 - 07:47 pm
opioids
opioid addiction
FDA
Probuphine
Braeburn Pharmaceuticals
Titan Pharmaceuticals
Sanofi Wins FDA Panel’s Backing for Once-Daily Diabetes Combo
Bloomberg
Wed, 05/25/16 - 09:35 pm
Sanofi
FDA
advisory panels
diabetes
lixisenatide
Lantus
In unanimous vote, FDA panel recommends Novo diabetes drug
BioPharma Dive
Wed, 05/25/16 - 09:28 pm
FDA
advisory panels
Novo Nordisk
diabetes
IDegLira
Is the FDA’s decision to delay Sarepta drug decision good or bad? Nobody really knows
Marketwatch
Wed, 05/25/16 - 09:21 pm
Sarepta Therapeutics
FDA
Duchenne Muscular Dystrophy
eteplirsen
FDA clears next-gen tattoo removal laser from Cynosure
Mass Device
Wed, 05/25/16 - 11:33 am
FDA
tattoo removal
Cynosure
devices
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