FDA

Medtronic lands U.S., E.U. wins for miniature cardiac monitor
Mass Device
Thu, 02/20/14 - 08:28 am
Europe
cardiac monitors
Medtronic
FDA
devices
Reveal LINQ
Pluristem Therapeutics submits FDA orphan drug application for PLX-PAD
The Fly on the Wall
Thu, 02/20/14 - 08:14 am
FDA
orphan drugs
Pluristem Therapeutics
PLX-PAD
preeclampsia
Should FDA and EMA Team up to Approve Drugs on a Reciprocal Basis?
Regulatory Focus
Wed, 02/19/14 - 08:57 am
FDA
drug approvals
Europe
EMA
Sun Pharma gains on U.S. FDA approval of bone drug
Yahoo/Reuters
Wed, 02/19/14 - 08:36 am
Sun Pharma
FDA
osteoporosis
Ibandronate Sodium
Roche
Chelsea Therapeutics Wins FDA Approval For Northera
TheStreet.com
Tue, 02/18/14 - 05:42 pm
FDA
Northera
Chelsea Therapeutics
neurogenic orthostatic hypotension
FDA head says working with India to improve drug quality, safety
Yahoo/Reuters
Tue, 02/18/14 - 08:55 am
FDA
India
quality
drug manufacturing
Why the FDA Still Won’t Approve J&J’s Blood Clot Medicine
Wall St Cheat Sheet
Sat, 02/15/14 - 11:12 am
FDA
JNJ
Xarelto
anti-clotting
Drug Quality Concerns Spur New U.S. FDA Oversight Effort
Bloomberg
Fri, 02/14/14 - 06:36 pm
FDA
India
generics
drug manufacturing
AstraZeneca's Crestor gets FDA orphan designation
Yahoo/Fly on the Wall
Fri, 02/14/14 - 06:31 pm
AstraZeneca
FDA
orphan drugs
Crestor
pediatric homozygous familial hypercholesterolemia
FDA approves BioMarin's genetic disorder drug Vimizim
Yahoo/Reuters
Fri, 02/14/14 - 06:29 pm
Biomarin
FDA
Vimizim
Morquio A Syndrome
Bayer says FDA rejects wider use of Xarelto drug
Yahoo/Reuters
Fri, 02/14/14 - 09:49 am
FDA
Bayer
Xarelto
Bayer says FDA rejects wider use of Xarelto drug
Yahoo/Reuters
Fri, 02/14/14 - 09:49 am
FDA
Bayer
Xarelto
Medicines Co. shares plummet after FDA follows through with rejection
Marketwatch
Thu, 02/13/14 - 11:51 am
FDA
Cangrelor
The Medicines Company
FDA rejects Durect's pitch to market post-operative pain therapy
Fierce Biotech
Thu, 02/13/14 - 09:22 am
FDA
Durect
post-operative pain
Chelsea Therapeutics: The Good, The Bad And The Ugly
Seeking Alpha
Thu, 02/13/14 - 09:12 am
Chelsea Therapeutics
FDA
Northera
FDA Advisory Panel Recommends Against Approval Of New Medicines Company Heart Drug
Forbes
Wed, 02/12/14 - 06:52 pm
FDA
advisory panels
The Medicines Company
Cangrelor
Senators question FDA over hydrocodone painkiller
Yahoo/AP
Wed, 02/12/14 - 06:50 pm
FDA
Senate
hydrocodone
Zohydro
Zogenix
J&J, Pharmacyclics drug gets U.S. approval for leukemia
Yahoo/Reuters
Wed, 02/12/14 - 06:46 pm
FDA
JNJ
Pharmacyclics
Imbruvica
chronic lymphocytic leukemia
What's Holding up FDA's Electronic Drug Labeling Rule?
Regulatory Focus
Wed, 02/12/14 - 12:02 pm
FDA
electronic labeling
Prediction: Chelsea Wins Northera FDA Approval Friday
TheStreet.com
Wed, 02/12/14 - 09:48 am
Chelsea Therapeutics
Northera
FDA

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