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FDA
Most drug makers report incomplete side effects to the FDA
Stat
Tue, 02/23/16 - 05:48 pm
FDA
side effects
Biogen
Senate vote removes major hurdle in Califf’s bid to lead FDA
Stat
Mon, 02/22/16 - 10:01 pm
Senate
Robert Califf
FDA
FDA sets LixiLan decision date for Sanofi-Novo diabetes showdown; Eylea could outshine Bayer's sales forecasts, analyst predicts
Fierce Pharma
Mon, 02/22/16 - 06:08 pm
FDA
LixiLan
Sanofi
Novo Nordisk
Bayer
Eylea
Trevena Pain Drug Anointed 'Breakthrough Therapy' by FDA
TheStreet.com
Mon, 02/22/16 - 10:03 am
Trevena
painkillers
breakthrough therapies
FDA
oliceridine
post-surgical pain
Medtronic Receives FDA Approval for Expanded Indication Trial in Low-Risk Aortic Stenosis Patients
Yahoo
Mon, 02/22/16 - 09:30 am
Medtronic
FDA
devices
CoreValve
aortic stenosis
Amarin and FDA near settlement on off-label free speech, ask court for 30 more days
Fierce Pharma
Sun, 02/21/16 - 11:38 am
Amarin
FDA
off-label
free speech
Vascepa
Novartis' blood cancer drug bags a 'breakthrough' tag on the way to FDA filing
Fierce Biotech
Fri, 02/19/16 - 11:10 am
Novartis
blood cancer
breakthrough status
PKC412
FDA
FDA approves UCB drug for treating epileptic seizures
Fierce Pharma
Fri, 02/19/16 - 11:09 am
FDA
UCB Pharma
epilepsy
seizures
Briviact
FDA panel recommends deep, long-term monitoring for leadless pacemakers
Mass Device
Fri, 02/19/16 - 10:11 am
FDA
devices
advisory panels
leadless pacemakers
Medtronic
St. Jude Medical
Boston Scientific
Biotronik
Congress targets FDA’s pre-market reviews, clinical trials for medical devices
Mass Device
Fri, 02/19/16 - 10:06 am
FDA
US Congress
devices
clinical trials
Analyst doubts FDA’s estimate of fetal deaths linked to Bayer’s Essure
Mass Device
Thu, 02/18/16 - 09:43 am
Bayer
Essure
devices
FDA
birth control
Masimo wins FDA nod for noninvasive sensors with the Root patient monitoring platform
Mass Device
Thu, 02/18/16 - 09:29 am
Masimo
FDA
patient monitors
Root patient monitoring
devices
FDA Approves Medtronic Deep Brain Stimulation for People with Parkinson's Disease with Recent Onset of Motor Complications
Yahoo
Wed, 02/17/16 - 09:52 pm
Medtronic
deep brain stimulation
FDA
Parkinson's Disease
Sandoz Petitions High Court to Review the Federal Circuit’s Decision on the BPCIA’s 180-Day Notice of Commercial Marketing Provision
FDA Law Blog
Wed, 02/17/16 - 11:33 am
Sandoz
FDA
BPCIA
Amgen
Zarxio
Neupogen
AstraZeneca wins FDA breakthrough status for key cancer drug
Yahoo/Reuters
Wed, 02/17/16 - 10:32 am
AstraZeneca
FDA
breakthrough status
durvalumab
bladder cancer
anti-PD-L1
FDA approves trial for J&J’s Mentor MemoryGel breast implant
Mass Device
Tue, 02/16/16 - 07:43 pm
FDA
JNJ
Mentor MemoryGel
breast implants
devices
FDA expands use of Gilead's liver drug to rare subset of patients
Yahoo/Reuters
Tue, 02/16/16 - 10:28 am
FDA
Gilead Sciences
Harvoni
Struggling Clovis to once again chase FDA favor for would-be Tagrisso competitor
BioPharma Dive
Tue, 02/16/16 - 10:26 am
Clovis Oncology
FDA
Tagrisso
rociletinib
Merck says U.S. FDA rejects its claim that Zetia and Vytorin cut heart risk
Yahoo/Reuters
Tue, 02/16/16 - 10:04 am
FDA
Merck
Zetia
Vytorin
3 Upcoming FDA Decisions We're Most Excited About
Motley Fool
Sat, 02/13/16 - 09:25 am
FDA
Acadia
Intercept Pharma
Clovis Oncology
Nuplazid
OCA
rociletinib
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