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advisory panels
FDA expert panel unanimously recommends approval for Horizon Therapeutics eye drug
Endpoints
Fri, 12/13/19 - 09:32 pm
FDA
advisory panels
Horizon Therapeutics
thyroid eye disease
teprotumumab
What's Next for Amarin's Stock?
Motley Fool
Fri, 11/15/19 - 10:41 am
Amarin
Vascepa
FDA
pharma stocks
advisory panels
The future of Vascepa sales, and Amarin, could hinge on next week's panel
EP Vantage
Tue, 11/5/19 - 10:28 am
Amarin
Vascepa
FDA
advisory panels
M&A
FDA Ad Com thumbs down on full Makena approval
Seeking Alpha
Tue, 10/29/19 - 11:00 pm
Makena
preterm birth
Amag Pharmaceuticals
FDA
advisory panels
Despite worries triggered by imbalance of deaths, Shionogi's antibiotic clears FDA panel vote
Endpoints
Thu, 10/17/19 - 10:28 am
Shionogi
FDA
advisory panels
antibiotics
cefiderocol
UTIs
In-house FDA review flags a suspicious imbalance in deaths as Shionogi hunts an OK for antibiotic
Endpoints
Mon, 10/14/19 - 10:26 am
Shionogi
FDA
advisory panels
antibiotics
UTIs
cefiderocol
GSK's oral nicotine spray wins divided FDA panel's backing despite abuse risks
Fierce Pharma
Thu, 09/19/19 - 12:35 pm
GSK
FDA
advisory panels
OTC
An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening
Stat
Fri, 09/13/19 - 10:18 am
FDA
advisory panels
peanut allergy
Aimmune Therapeutics
Palforzia
Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting
Fierce Pharma
Thu, 08/8/19 - 11:36 pm
Amarin
Vascepa
advisory panels
FDA
13 Keys to a Successful FDA Advisory Committee Meeting
RAPS.org
Sun, 08/4/19 - 01:04 pm
FDA
advisory panels
Amarin boosted as another milestone to the FDA’s big Vascepa decision flies by with no sign of an AdCom
Endpoints
Wed, 07/31/19 - 10:30 am
FDA
Amarin
Vascepa
advisory panels
earnings
FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble
Stat
Tue, 07/23/19 - 07:41 pm
Intra-Cellular Therapies
FDA
advisory panels
schizophrenia
lumateperone
FDA overrides adcomm opinions a fifth of the time, study finds — but why?
Endpoints
Thu, 07/18/19 - 10:13 am
FDA
advisory panels
U.S. advisory panel stops short of broad recommendations for two common vaccines
Stat
Wed, 06/26/19 - 05:15 pm
FDA
vaccines
HPV
pneumonia
advisory panels
Merck
Gardasil
Pfizer
Prevnar 13
Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears
RAPS.org
Thu, 06/20/19 - 07:57 pm
FDA
paclitaxel
devices
advisory panels
FDA panel does not back broad reach of Sanofi's dengue vaccine
BioCentury
Fri, 03/8/19 - 10:57 pm
Sanofi
dengue
Dengvaxia
FDA
advisory panels
FDA experts offer a big thumbs up for J&J’s flawed application to market esketamine for major depression — but trial failures, safety questions spur concerns
Endpoints
Tue, 02/12/19 - 04:21 pm
JNJ
FDA
advisory panels
esketamine
major depression
Approving J&J's new depression drug would be an unusual move for the FDA
BioPharma Dive
Sun, 02/10/19 - 01:49 pm
JNJ
esketamine
FDA
advisory panels
FDA advisers divided on Sanofi’s oral type 1 diabetes drug
Pharmaforum
Fri, 01/18/19 - 10:26 am
Sanofi
Lexicon Pharmaceuticals
type 1 diabetes
Zynquista
FDA
advisory panels
sotagliflozin
Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote
Fierce Pharma
Thu, 01/17/19 - 12:06 am
Amgen
osteoporosis
Evenity
romosozumab
FDA
advisory panels
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