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FDA
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
Clovis Oncology Issues Update On Rociletinib, Will Meet With FDA On April 12
Yahoo/Benzinga
Fri, 02/12/16 - 04:25 pm
Clovis Oncology
rociletinib
FDA
non-small cell lung cancer
Intercept books a date with the FDA as buyout rumors simmer
Fierce Biotech
Thu, 02/11/16 - 09:03 pm
Intercept Pharma
FDA
M&A
FDA puts full clinical hold on CTI BioPharma's blood cancer drug
Yahoo/Reuters
Wed, 02/10/16 - 03:21 pm
CTI BioPharma
FDA
blood cancer
pacritinib
Pfizer Commends The FDA Advisory Committee’s Vote To Approve Proposed Biosimilar Infliximab, The First Biosimilar Monoclonal Antibody Reviewed, For All Eligible Indications
Yahoo
Wed, 02/10/16 - 09:37 am
FDA
Pfizer
advisory panels
biosimilars
infliximab
Celltrion
FDA warning to Ipca Labs shines light on rampant data falsification
Fierce Pharma Manufacturing
Wed, 02/10/16 - 09:35 am
FDA
warnings
Ipca Labs
drug manufacturing
FDA panel backs Pfizer and Celltrion's Remicade biosimilar over J&J's objections
Fierce Biotech
Tue, 02/9/16 - 05:35 pm
FDA
advisory panels
Pfizer
Celltrion
Remicade
JNJ
biosimilars
Eisai Says That the Recently Enacted IRTNMTA Should Result in a Longer PTE for FYCOMPA Patent
FDA Law Blog
Tue, 02/9/16 - 09:16 am
Eisai
IRTNMTA
FDA
Fycompa
FDA wants answers from Medtronic, St. Jude on leadless pacers
Mass Device
Mon, 02/8/16 - 09:37 pm
FDA
Medtronic
St. Jude Medical
leadless pacemakers
US FDA prioritizes devices requiring human factors reviews
Mass Device
Mon, 02/8/16 - 09:36 pm
FDA
devices
Sarepta's Duchenne drug decision delayed: Why it could help win approval
Bizjournals.com
Mon, 02/8/16 - 12:47 pm
Sarepta Therapeutics
Duchenne Muscular Dystrophy
FDA
eteplirsen
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