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FDA
FDA warns of kidney risks for diabetes drugs from Janssen, AstraZeneca
BioPharma Dive
Tue, 06/14/16 - 07:27 pm
FDA
diabetes
Janssen
JNJ
AstraZeneca
Farxiga
Invokana
FDA approves weight-loss device that drains out undigested food
Stat
Tue, 06/14/16 - 07:25 pm
FDA
devices
obesity
AspireAssist
Aspire Bariatrics
FDA approves world's first single-dose cholera vaccine
BioPharma Dive
Tue, 06/14/16 - 09:59 am
FDA
cholera
vaccines
Vaxchora
PaxVax
FDA overrides adcomm, shoots down KemPharm’s opioid
Fierce Biotech
Mon, 06/13/16 - 11:29 pm
FDA
advisory panels
KemPharm
Apadaz
opioids
painkillers
Sanofi's diabetes drug hits trial targets, heads for final approval
BioPharma Dive
Mon, 06/13/16 - 11:27 am
Sanofi
diabetes
LixiLan
FDA
PaxVax's cholera vaccine wins FDA nod
Fierce Pharma
Sat, 06/11/16 - 10:20 am
PaxVax
cholera
vaccines
FDA
Vaxchora
A new report from the IMS Institute for Health Informatics highlights the plights and promises of the rapidly growing cancer drug industry
Motley Fool
Sat, 06/11/16 - 10:17 am
cancer
oncology
FDA
FDA’s device evaluation program is underway
Mass Device
Fri, 06/10/16 - 04:12 pm
FDA
devices
Positive FDA Committee Vote on Vantrela Bodes Well for Remoxy
Investopedia
Fri, 06/10/16 - 04:04 pm
FDA
Vantrela
Teva Pharmaceutical
Pain Therapeutics
Durect
Remoxy
ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living With HIV
Yahoo
Fri, 06/10/16 - 10:06 am
ViiV Healthcare
HIV
FDA
pediatric
Dolutegravir
U.S. regulator says too many drugmakers chasing same cancer strategy
Yahoo/Reuters
Fri, 06/10/16 - 08:53 am
FDA
oncology
ASCO 2016
Merck
Bristol-Myers Squibb
PD-1 inhibitors
U.S. regulatory panel backs approval for Merck C. difficile drug
Yahoo/Reuters
Thu, 06/9/16 - 09:57 pm
FDA
Merck
C. difficile
advisory panels
bezlotoxumab
Troubled Teva plant in Hungary faces an FDA crackdown
Stat
Thu, 06/9/16 - 09:52 am
Teva Pharmaceutical
drug manufacturing
FDA
Hungary
Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR Petition
FDA Law Blog
Thu, 06/9/16 - 09:48 am
FDA
orphan drugs
Crestor
505A(o)
FDA panel backs approval of Pfizer's opioid painkiller
Yahoo/Reuters
Wed, 06/8/16 - 09:26 pm
FDA
advisory panels
Pfizer
opioids
painkillers
Troxyca ER
FDA approves Allergan's fixed-dose combo for hyertension
BioPharma Dive
Wed, 06/8/16 - 05:07 pm
FDA
Allergan
hypertension
Byvalson
FDA chief aims to recruit 100 million Americans for precision medicine research
Stat
Wed, 06/8/16 - 10:35 am
FDA
precision medicine
Robert Califf
Precision Medicine Initiative
FDA panel backs Teva’s new abuse-deterrent opioid
Pharma Times
Wed, 06/8/16 - 09:56 am
FDA
advisory panels
Teva Pharmaceutical
opioids
Vantrela
abuse-resistant painkillers
FDA staff review questions efficacy of Merck's C. difficile drug
Yahoo/Reuters
Tue, 06/7/16 - 04:23 pm
FDA
Merck
C. difficile
bezlotoxumab
FDA, Sandoz Prevail at D.C. Circuit on Generic FUSILEV Approval
FDA Law Blog
Mon, 06/6/16 - 11:12 pm
FDA
Sandoz
Fusilev
generics
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