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FDA
The Regulatory Quagmire Of Treatments For Sickle Cell Disease
Forbes
Thu, 07/2/15 - 11:17 am
sickle cell disease
regulatory
FDA
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF)
Yahoo
Wed, 07/1/15 - 10:51 pm
Gilead Sciences
HIV
R/F/TAF
FDA
Bad news for AstraZeneca: FDA lays out roadmap for would-be Symbicort copycats
Fierce Pharma
Wed, 07/1/15 - 04:10 pm
FDA
AstraZeneca
Symbicort
biosimilars
FDA taps the brakes on Genentech's cobimetinib review
Fierce Biotech
Wed, 07/1/15 - 04:08 pm
FDA
Genentech
Cobimetinib
melanoma
Exelixis
Purdue pulls out of FDA panel on abuse-deterrent OxyContin just days before meeting
Fierce Biotech
Wed, 07/1/15 - 04:07 pm
Purdue
painkillers
FDA
advisory panels
oxycontin
FDA OKs second test to see if Essure contraceptive is placed right
Yahoo/Reuters
Wed, 07/1/15 - 12:03 pm
FDA
Essure
contraceptives
devices
Bayer
House bill would force FDA to ease up on social media
Fierce Pharma Marketing
Wed, 07/1/15 - 10:47 am
FDA
social media
FDA addresses UDI direct marking for reprocessed devices
Mass Device
Wed, 07/1/15 - 10:42 am
FDA
devices
reprocessed medical devices
UDI
5 Biotech Stocks On Deck With The FDA
Yahoo/Benzinga
Tue, 06/30/15 - 06:13 pm
FDA
Alnylam
Patisiran
Esperion Therapeutics
ETC-1002
Intercept Pharmaceuticals
obeticholic acid
Sarepta Therapeutics
eteplirsen
Tekmira
TKM-PLK1
Vertex Approaches Its Make-or-Break Day
Investopedia
Tue, 06/30/15 - 06:09 pm
Vertex Pharmaceuticals
Orkambi
cystic fibrosis
FDA
FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data
WSJ Pharmalot
Mon, 06/29/15 - 11:37 am
FDA
Gilead Sciences
hepatitis C
clinical trial data
Vertex Profits Hinge on FDA Approving New Cystic Fibrosis Drug This Week
TheStreet.com
Mon, 06/29/15 - 11:31 am
Vertex Pharmaceuticals
FDA
cystic fibrosis
Orkambi
Sarepta Submits DMD Drug for FDA Approval Review
TheStreet.com
Mon, 06/29/15 - 10:48 am
FDA
Sarepta Therapeutics
Duchenne Muscular Dystrophy
eteplirsen
U.S. FDA Grants Priority Review for MM-398 New Drug Application
Yahoo
Thu, 06/25/15 - 08:59 am
FDA
MM-398
Merrimack Pharmaceuticals
metastatic pancreatic cancer
Prometheus Takes Action Against FDA Over Generic LOTRONEX Approval and REMS Waiver, and Then Promptly Drops Case
FDA Law Blog
Thu, 06/25/15 - 08:57 am
FDA
Prometheus
generics
Lotronix
FDA to hold public meeting to discuss safety, effectiveness of Bayer's Essure contraceptive device
First Word Med Tech
Thu, 06/25/15 - 08:31 am
FDA
Essure
birth control
devices
Bayer
FDA to make announcement Wednesday about birth control device Essure
ABC News
Wed, 06/24/15 - 09:04 am
FDA
Essure
devices
FDA approves new version of Medtronic's heart valve device
Yahoo/Reuters
Wed, 06/24/15 - 08:32 am
FDA
Medtronic
devices
Heart Valve Replacement
Evolut-R
Torax Medical wins FDA nod for MRI compatible Linx
Mass Device
Wed, 06/24/15 - 08:18 am
FDA
Torax Medical
devices
reflux
Linx reflux management
A Bill Would Prevent Drug Makers From Frustrating Generic Rivals
WSJ Pharmalot
Tue, 06/23/15 - 10:40 am
generics
REMS
patient safety
FDA
FTC
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