FDA

FDA Policy: Is Off-Label on the Table?
Medical Marketing and Media
Wed, 04/29/15 - 11:42 am
FDA
off-label
Good news for Lilly: Cyramza nabs yet another FDA approval
BioPharma Dive
Tue, 04/28/15 - 09:06 pm
Eli Lilly
Cyramza
FDA
colorectal cancer
FDA approves generic versions of antipsychotic drug Abilify
Yahoo/Reuters
Tue, 04/28/15 - 09:05 pm
FDA
generics
Abilify
Bristol-Myers Squibb
antipsychotics
FDA bats down Merck's sugammadex in third rejection
Fierce Biotech
Tue, 04/28/15 - 09:01 pm
FDA
Merck
sugammadex
Bridion
FDA Grants Fast Track Designation to Genzyme’s Investigational Substrate Reduction Therapy for the Treatment of Fabry Disease
Yahoo
Tue, 04/28/15 - 08:50 am
FDA
fast track
Genzyme
Fabry's disease
GZ/SAR402671
Sanofi
FDA review challenges Amgen on a questionable T-Vec study
Fierce Biotech
Mon, 04/27/15 - 09:46 am
FDA
Amgen
T-Vec
Talimogene Laherparepvec
cancer
cancer vaccines
A Drug That Destroys Fat Cells Could Make Kythera's Stock Look Beautiful
Seeking Alpha
Sat, 04/25/15 - 09:27 am
Kythera
ATX-101
FDA
Richard Burr (R-N.C.) introduces a new bill to create fast-track approvals at the FDA for breakthrough medical devices
Mass Device
Sat, 04/25/15 - 08:41 am
FDA
devices
fast track
FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C
Marketwatch
Fri, 04/24/15 - 10:55 am
FDA
AbbVie
OBV/PTV/r
Chronic Hepatitis C
US FDA explains criteria for accepting medical device clinical data from foreign studies
Mass Device
Fri, 04/24/15 - 09:28 am
devices
FDA
Clinical Data
FDA gives Boehringer's Pradaxa antidote a boost with fast-track review
Fierce Pharma
Thu, 04/23/15 - 01:34 pm
FDA
Boehringer Ingelheim
fast track
Pradaxa
idarucizumab
What Adverse Event Reports? FDA Warns Galena For a Lack of Procedures
WSJ Pharmalot
Wed, 04/22/15 - 01:51 pm
FDA
adverse events
Galena Biopharma
Abstral
FDA panel issues aneurysm device recommendations
Mass Device
Tue, 04/21/15 - 01:35 pm
FDA
advisory panels
devices
aneurysms
Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer
Yahoo
Tue, 04/21/15 - 12:18 pm
Pfizer
Xalkori
non-small cell lung cancer
FDA
PAD: FDA clears new orbital atherectomy device from Cardiovascular Systems
Mass Device
Tue, 04/21/15 - 12:17 pm
PAD
peripheral artery disease
atherectomy
devices
FDA
Diamondback 360
Cardiovascular Systems
Merck's Keytruda shrinks lung cancer tumors, FDA approval sought
Yahoo/Reuters
Sun, 04/19/15 - 12:02 pm
Merck
Keytruda
lung cancer
FDA
non-small cell lung cancer
PDL-1 inhibitors
The FDA calls on Genervon to release data from controversial ALS study
Fierce Biotech
Fri, 04/17/15 - 10:31 am
FDA
Genervon
ALS
GM604
FDA Approves Generic Copaxone, but When Will it Become Available?
WSJ Pharmalot
Fri, 04/17/15 - 08:39 am
FDA
generics
Copaxone
MS
multiple sclerosis
Teva Pharmaceutical
FDA approves first generic version of Teva MS drug Copaxone
Yahoo/Reuters
Thu, 04/16/15 - 09:46 pm
FDA
generics
Teva Pharmaceutical
Copaxone
MS
multiple sclerosis
Conventus Orthopaedics wins FDA clearance for shoulder fracture fixation device
Mass Device
Thu, 04/16/15 - 10:59 am
Conventus Orthpaedics
FDA
devices
shoulder fractures
humeral fractures
PH Cage

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