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» FDA
FDA
Drug maker in trouble with FDA for failing to report side effects
Stat
Wed, 11/18/15 - 03:21 pm
FDA
Heritage Pharmaceuticals
Medtronic wins FDA nod for app-based remote pacer monitor
Mass Device
Wed, 11/18/15 - 09:26 am
Medtronic
FDA
devices
MyCareLink Smart Monitor
Califf: I’ll never lower FDA’s approval standards
Stat
Wed, 11/18/15 - 09:24 am
Robert Califf
FDA
drug approvals
Bristol-Myers nabs FDA priority review for new Opdivo use in kidney cancer
Fierce Pharma
Tue, 11/17/15 - 05:57 pm
Bristol-Myers Squibb
FDA
priority review
Opdivo
kidney cancer
The FDA asked this company for some data and now its stock is down 72%
Yahoo/Business Insider
Mon, 11/16/15 - 03:31 pm
Clovis Oncology
FDA
rociletinib
J&J nabs an early OK for 'breakthrough' multiple myeloma blockbuster contender Darzalex
Fierce Biotech
Mon, 11/16/15 - 03:29 pm
JNJ
Multiple Myeloma
daratumumab
FDA
Darzalex
Genmab
In major victory, AstraZeneca wins FDA approval for potential $3B lung cancer med
BioPharma Dive
Mon, 11/16/15 - 11:54 am
AstraZeneca
FDA
Tagrisso
non-small cell lung cancer
FDA nominee Robert Califf must prove his independence from industry
Pharmalot
Mon, 11/16/15 - 11:53 am
FDA
Robert Califf
Clovis Oncology Gets Hit Hard: FDA Delays Approval
Bidness, ETC
Mon, 11/16/15 - 09:18 am
Clovis Oncology
FDA
rociletinib
non-small cell lung cancer
Drug makers beat diabetes lawsuits with an unusual ruling
Pharmalot
Fri, 11/13/15 - 08:49 pm
diabetes
FDA
labeling
Merck
Novo Nordisk
Eli Lilly
FDA approves Baxalta's drug for rare bleeding disorder
Yahoo/Reuters
Fri, 11/13/15 - 08:45 pm
Baxalta
FDA
Adynovate
AstraZeneca wins big with fast FDA OK of AZD9291 for lung cancer
Fierce Biotech
Fri, 11/13/15 - 08:38 pm
AstraZeneca
FDA
fast track
AZD9291
lung cancer
AbbVie Submits IMBRUVICA® (ibrutinib) Phase III Combination Data to U.S. FDA
Yahoo
Fri, 11/13/15 - 10:59 am
AbbVie
Imbruvica
bendamustine
rituximab
chronic lymphocytic leukemia
FDA
FDA approves Gilead's hepatitis C drug for expanded use
Yahoo/Reuters
Fri, 11/13/15 - 10:05 am
FDA
Gilead Sciences
hepatitis C
Harvoni
Panel recommends Merck continue cholesterol drug study
Yahoo/Reuters
Fri, 11/13/15 - 10:03 am
FDA
advisory panels
Merck
Anacetrapib
The FDA eases up on Forum's schizophrenia program with Alzheimer's trials still on hold
Fierce Biotech
Thu, 11/12/15 - 09:22 am
Forum Pharmaceuticals
FDA
schizophrenia
Alzheimer's disease
encenicline
FDA approves Genentech's Cotellic as part of melanoma combo
BioPharma Dive
Wed, 11/11/15 - 09:28 pm
FDA
Genentech
Cotellic
melanoma
Zelboraf
Collegium's pain drug wins a 'tentative' FDA approval with Purdue blocking the way
Fierce Biotech
Mon, 11/9/15 - 03:45 pm
Collegium Pharmaceutical
FDA
painkillers
Xtampza ER
Purdue Pharma
Dr. Reddy's feels FDA heat, gets warning letter for three plants
Fierce Pharma
Sat, 11/7/15 - 11:36 am
Dr Reddy's
FDA
warnings
drug manufacturing
India
FDA panel backs Merck & Co drug to reverse muscle relaxant effect
Yahoo/Reuters
Fri, 11/6/15 - 03:28 pm
Merck
FDA
suggammadex
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