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FDA
FDA approves new leads for Nevro’s Senza spinal cord stimulator
Mass Device
Mon, 04/18/16 - 11:04 am
FDA
Nevro
Senza
spinal cord stimulator
devices
FDA's Draft Guidance on Data Integrity: The Cupola on a Tower of Guidances
FDA Law Blog
Mon, 04/18/16 - 10:04 am
FDA
data integrity
The FDA Wants Pharma to Ditch its Archaic Drug Making Process
Fortune
Thu, 04/14/16 - 09:21 pm
FDA
drug manufacturing
Repros to drop testosterone drug in U.S. if key study fails
Yahoo/Reuters
Thu, 04/14/16 - 04:43 pm
Repros
testosterone
FDA
clinical trials
Androxal
uterine fibroids
Proellex
Chiasma's Acromegaly Drug Headed for FDA Rejection, Investor Says
TheStreet.com
Thu, 04/14/16 - 10:08 am
Chiasma
acromegaly
FDA
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Supplemental Biologics License Application for Opdivo® (nivolumab) for the Treatment of Classical Hodgkin Lymphoma Patients
Yahoo
Thu, 04/14/16 - 09:13 am
Bristol-Myers Squibb
Opdivo
Hodgkin's lymphoma
FDA
Merck Says FDA Accepts Its sBLA For Keytruda And Grants Priority Review
Yahoo/Benzinga
Wed, 04/13/16 - 09:55 am
Merck
FDA
Keytruda
metastatic head and neck squamous cell carcinoma
Clovis Lung Cancer Drug Trashed at FDA Panel, CEO Exit Next?
TheStreet.com
Tue, 04/12/16 - 03:43 pm
Clovis Oncology
FDA
advisory panels
rociletinib
Pat Mahaffy
FDA clears Nephros after 2015 warning letter
Mass Device
Mon, 04/11/16 - 11:21 pm
FDA
Nephros
warnings
devices
AbbVie wins FDA approval for leukemia drug
BioPharma Dive
Mon, 04/11/16 - 05:22 pm
AbbVie
FDA
Venclexta
CLL
Genentech
New name, but same old problems for Posimir as FDA hits Durect again
Fierce Biotech
Sat, 04/9/16 - 09:30 am
Posimir
FDA
Durect
Posidur
gall bladder surgery
FDA approval nearly doubles potential U.S. patients for Abiomed’s heart pump
Bizjournals.com
Fri, 04/8/16 - 09:34 pm
FDA
Abiomed
cardiac shock
devices
FDA staff questions Clovis drug's benefit over current treatments
Yahoo/Reuters
Fri, 04/8/16 - 11:08 am
FDA
Clovis Oncology
rociletinib
non-small cell lung cancer
FDA approves Abiomed's device to treat cardiac shocks
Yahoo/Reuters
Fri, 04/8/16 - 10:54 am
FDA
Abiomed
cardiac shock
devices
Impella
FDA advisory panel supports quick approval for Intercept's drug OCA for liver disease
Fierce Biotech
Thu, 04/7/16 - 09:40 pm
FDA
advisory panels
Intercept Pharma
OCA
primary biliary cirrhosis
FDA approves first pacemaker without wires from Medtronic
Yahoo/AP
Thu, 04/7/16 - 10:05 am
FDA
Medtronic
wireless pacemakers
devices
Micra Transcatheter Pacing System
FDA Licenses a Second Biosimilar – The Parameters of Approval Come Into Better Focus
FDA Law Blog
Thu, 04/7/16 - 09:49 am
FDA
biosimilars
JNJ
Remicade
Inflectra
Pfizer
Celltrion
FDA warns on heart failure risk associated with Onglyza, Nesina
BioPharma Dive
Wed, 04/6/16 - 10:13 pm
FDA
heart failure
Onglyza
Nesina
AstraZeneca
Takeda
diabetes
The FDA Just Approved Another Next-Gen Gilead HIV Drug
Fortune
Tue, 04/5/16 - 10:28 pm
FDA
Descovy
Gilead Sciences
HIV
FDA approves 1st cheaper version of J&J's top drug Remicade
Yahoo/AP
Tue, 04/5/16 - 10:16 pm
FDA
Remicade
JNJ
Inflectra
biosimilars
Celltrion
Pfizer
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