advisory panels

An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening
An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening
Stat
FDA
advisory panels
peanut allergy
Aimmune Therapeutics
Palforzia
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Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting
Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting
Fierce Pharma
Amarin
Vascepa
advisory panels
FDA
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13 Keys to a Successful FDA Advisory Committee Meeting
13 Keys to a Successful FDA Advisory Committee Meeting
RAPS.org
FDA
advisory panels
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Amarin boosted as another milestone to the FDA’s big Vascepa decision flies by with no sign of an AdCom
Amarin boosted as another milestone to the FDA’s big Vascepa decision flies by with no sign of an AdCom
Endpoints
FDA
Amarin
Vascepa
advisory panels
earnings
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FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble
FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble
Stat
Intra-Cellular Therapies
FDA
advisory panels
schizophrenia
lumateperone
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FDA overrides adcomm opinions a fifth of the time, study finds — but why?
FDA overrides adcomm opinions a fifth of the time, study finds — but why?
Endpoints
FDA
advisory panels
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U.S. advisory panel stops short of broad recommendations for two common vaccines
U.S. advisory panel stops short of broad recommendations for two common vaccines
Stat
FDA
vaccines
HPV
pneumonia
advisory panels
Merck
Gardasil
Pfizer
Prevnar 13
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Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears
Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears
RAPS.org
FDA
paclitaxel
devices
advisory panels
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FDA panel does not back broad reach of Sanofi's dengue vaccine
FDA panel does not back broad reach of Sanofi's dengue vaccine
BioCentury
Sanofi
dengue
Dengvaxia
FDA
advisory panels
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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
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
JNJ
FDA
advisory panels
esketamine
major depression
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Approving J&J's new depression drug would be an unusual move for the FDA
Approving J&J's new depression drug would be an unusual move for the FDA
BioPharma Dive
JNJ
esketamine
FDA
advisory panels
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FDA advisers divided on Sanofi’s oral type 1 diabetes drug
FDA advisers divided on Sanofi’s oral type 1 diabetes drug
Pharmaforum
Sanofi
Lexicon Pharmaceuticals
type 1 diabetes
Zynquista
FDA
advisory panels
sotagliflozin
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Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote
Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote
Fierce Pharma
Amgen
osteoporosis
Evenity
romosozumab
FDA
advisory panels
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Naloxone Availability: FDA Meeting Next Week
Naloxone Availability: FDA Meeting Next Week
RAPS.org
FDA
advisory panels
opioids
opioid crisis
opioid overdose
Naloxone
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FDA advisory panel to mull transvaginal mesh
FDA advisory panel to mull transvaginal mesh
Mass Device
FDA
devices
transvaginal mesh
advisory panels
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With FDA Panel’s Nod, First Postpartum Depression Drug Nears Approval
With FDA Panel’s Nod, First Postpartum Depression Drug Nears Approval
Xconomy
FDA
advisory panels
SAGE Therapeutics
postpartum depression
brexanolone
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Alkermes Depression Drug Faces Long Odds After FDA Advisors Say No
Alkermes Depression Drug Faces Long Odds After FDA Advisors Say No
Xconomy
Alkermes
FDA
advisory panels
ALKS-5461
major depressive disorder
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FDA advisers back Shire constipation drug
FDA advisers back Shire constipation drug
Pharmaforum
FDA
Shire
advisory panels
prucalopride
CIC
chronic idiopathic constipation
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Advisory panel narrowly rejects oliceridine for acute pain
Advisory panel narrowly rejects oliceridine for acute pain
BioCentury
FDA
advisory panels
Trevena
TRV130
severe pain
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FDA panel unanimously backs Celltrion's Rituxan biosimilar
FDA panel unanimously backs Celltrion's Rituxan biosimilar
Fierce Pharma
Celltrion
Teva Pharmaceutical
biosimilars
Rituxan
FDA
advisory panels
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