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FDA
Will FDA advisers shoot down Amgen's cancer vaccine?
Fierce Biotech
Thu, 02/12/15 - 02:15 pm
FDA
Amgen
vaccines
T-Vec
melanoma
Competition to J&J's Remicade looms in U.S. as biosimilar conquers new markets
Fierce Biotech
Wed, 02/11/15 - 08:57 am
JNJ
Remicade
biosimilars
FDA
Celltrion
Remsima
FDA puts off Mylan's Nexium generic, giving Teva's version free rein
Fierce Pharma
Tue, 02/10/15 - 10:47 am
FDA
Mylan Labs
Nexium
generics
Teva Pharmaceuticals
AstraZeneca
FDA OKs Silk Road Medical's anti-stroke Enroute device
Mass Device
Tue, 02/10/15 - 08:44 am
FDA
Silk Road Medical
stroke
devices
Enroute
Roche's blockbuster Lucentis nabs fourth FDA approval
BioPharma Dive
Mon, 02/9/15 - 06:01 pm
Roche
Lucentis
FDA
DME
diabetic macular edema
FDA to pharma: Scrap that fine-print risk info in DTC ads
Fierce Pharma
Mon, 02/9/15 - 12:48 pm
FDA
consumer advertising
FDA warning for blockbuster hopeful edoxaban hits Daiichi where it hurts
BioPharma Dive
Mon, 02/9/15 - 11:08 am
FDA
warnings
Daiichi Sankyo
edoxaban
Why the FDA wants to double inspectors at Indian manufacturing facilities
BioPharma Dive
Fri, 02/6/15 - 10:58 am
FDA
India
drug manufacturing
The Hamburg Legacy at FDA: Accomplishments and Controversies
WSJ Pharmalot
Thu, 02/5/15 - 01:56 pm
FDA
Margaret Hamburg
FDA chief Hamburg reportedly to resign at end of March
BioPharma Dive
Thu, 02/5/15 - 01:55 pm
FDA
Margaret Hamburg
FDA wants to go on a hiring spree to fulfill 'precision' promise
Fierce Biotech
Wed, 02/4/15 - 10:10 am
FDA
hirings
Precision Medicine Initiative
FDA Issues Another Warning Letter to Apotex Over Manufacturing Problems
WSJ Pharmalot
Wed, 02/4/15 - 10:10 am
FDA
warnings
drug manufacturing
Apotex
Medtronic wins FDA approval for Melody pulmonary valve
Mass Device
Wed, 02/4/15 - 09:56 am
Medtronic
Medtronic Melody Transcatheter Pulmonary Valve
pulmonary valves
devices
FDA
Pfizer breast cancer drug gets early FDA approval
Yahoo/AP
Wed, 02/4/15 - 09:07 am
Pfizer
palbociclib
HER-2 postive breast cancer
breast cancer
FDA
FDA yanks 'breakthrough' bragging rights to Merck's hep C combo
Fierce Biotech
Wed, 02/4/15 - 08:36 am
FDA
Merck
hepatitis C
grazoprevir
elbasvir
Merck finally rolls out sleep aid Belsomra after FDA roadblocks
Fierce Pharma
Wed, 02/4/15 - 08:34 am
Merck
Belsomra
insomnia
FDA
suvorexant
FDA’s Novel Year of Novel Drug Approvals – 2014
Eye on FDA
Tue, 02/3/15 - 09:19 am
FDA
drug approvals
FDA Grants Breakthrough Therapy Designation To Genetech’s Cancer Immunotherapy
Bidness Etc.
Tue, 02/3/15 - 09:07 am
FDA
breakthrough therapies
Genentech
anti-PD-L1
MPDL3280A
non-small cell lung cancer
Novartis Wins FDA Approval For Ocular Allergy Solution, Pazeo (TM)
Bidness Etc.
Mon, 02/2/15 - 05:48 pm
Novartis
FDA
ocular allergies
Alcon
Pazeo
FDA System for Reporting Side Effects Needs a ‘Thorough Overhaul:’ Study
WSJ Pharmalot
Mon, 02/2/15 - 03:23 pm
side effects
FDA
adverse events
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