advisory panels

FDA’s adcomm process needs reform, researchers say
FDA’s adcomm process needs reform, researchers say
RAPS.org
FDA
regulatory
advisory panels
transparency
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FDA's use of adcomms prior to drug approval decreased over the last decade
FDA's use of adcomms prior to drug approval decreased over the last decade
RAPS.org
FDA
regulatory
advisory panels
drug approvals
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As Pfizer's booster AdComm nears, FDA staffers say COVID vaccines are already working as intended
As Pfizer's booster AdComm nears, FDA staffers say COVID vaccines are already working as intended
Fierce Pharma
FDA
Pfizer
vaccines
COVID-19
boosters
advisory panels
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FDA convenes adcomm for Pfizer COVID booster
FDA convenes adcomm for Pfizer COVID booster
RAPS.org
FDA
vaccines
COVID-19
boosters
Pfizer
BioNTech
advisory panels
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FibroGen slides after FDA posted documents ahead of AdCom meeting on Roxadustat
FibroGen slides after FDA posted documents ahead of AdCom meeting on Roxadustat
Seeking Alpha
FibroGen
FDA
roxadustat
advisory panels
chronic kidney disease
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Provention Bio, in need of AdComm's support for diabetes drug, may have what it needs to satisfy the FDA
Provention Bio, in need of AdComm's support for diabetes drug, may have what it needs to satisfy the FDA
Fierce Biotech
Provention Bio
FDA
advisory panels
diabetes
teplizumab
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Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug
Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug
Endpoints
FDA
advisory panels
ChemoCentryx
avacopan
ANCA-positive vasculitis
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FDA Advisory Committee Raises Objections to Pfizer and Eli Lilly’s Tanezumab
FDA Advisory Committee Raises Objections to Pfizer and Eli Lilly’s Tanezumab
BioSpace
FDA
advisory panels
Pfizer
Eli Lilly
tanezumab
osteoarthritis
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Pfizer has run 41 trials over 15 years for tanezumab. As adcomm nears, the FDA remains unimpressed — and more than a little worried
Pfizer has run 41 trials over 15 years for tanezumab. As adcomm nears, the FDA remains unimpressed — and more than a little worried
Endpoints
Pfizer
Eli Lilly
tanezumab
FDA
advisory panels
osteoarthritis
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FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA
FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA
Fierce Biotech
FDA
JNJ
advisory panels
vaccines
COVID-19
Emergency Use Authorization
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FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt
FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt
Biopharma Dive
Biogen
aducanumab
FDA
advisory panels
Alzheimer's disease
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FDA scientists appear to offer major endorsement of Biogen’s controversial Alzheimer’s treatment
FDA scientists appear to offer major endorsement of Biogen’s controversial Alzheimer’s treatment
Stat
Biogen
aducanumab
Alzheimer's disease
FDA
advisory panels
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Biogen Alzheimer's Drug Headed For Unfavorable Vote, Says An Analyst's Mock Panel
Biogen Alzheimer's Drug Headed For Unfavorable Vote, Says An Analyst's Mock Panel
Investors Business Daily
Biogen
aducanumab
Alzheimer's disease
FDA
analysts
advisory panels
mock advisory panels
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FDA Panel Vote Weighs in Favor of Alkermes Psyche Drug, With Caveats
FDA Panel Vote Weighs in Favor of Alkermes Psyche Drug, With Caveats
Xconomy
Alkermes
FDA
advisory panels
ALKS 3831
schizophrenia
bipolar disorder
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FDA Panel Votes 8-7 in Favor of Mallinckrodt's HRS-1 Drug
FDA Panel Votes 8-7 in Favor of Mallinckrodt's HRS-1 Drug
BioSpace
Mallinckrodt
FDA
terlipressin
HRS-1
advisory panels
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FDA panel to review GlaxoSmithKline multiple myeloma drug next month
FDA panel to review GlaxoSmithKline multiple myeloma drug next month
MedCity News
belantamab mafodotin
GSK
Multiple Myeloma
FDA
advisory panels
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FDA moots virtual AdComms but delays GSK, Intercept meetings
FDA moots virtual AdComms but delays GSK, Intercept meetings
Fierce Biotech
FDA
advisory panels
GSK
Intercept Pharma
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Lilly’s Cyramza closer to first-line lung cancer use after ODAC verdict
Lilly’s Cyramza closer to first-line lung cancer use after ODAC verdict
Pharmaforum
Eli Lilly
Cyramza
non-small cell lung cancer
FDA
advisory panels
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FDA's Advisory Committee to Review Claims That GlaxoSmithKline's Trelegy Ellipta Reduces Mortality
FDA's Advisory Committee to Review Claims That GlaxoSmithKline's Trelegy Ellipta Reduces Mortality
Motley Fool
GSK
FDA
advisory panels
COPD
Trelegy Ellipta
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AZ, Merck's Lynparza narrowly snags FDA panel backing in pancreatic cancer
AZ, Merck's Lynparza narrowly snags FDA panel backing in pancreatic cancer
Fierce Pharma
AstraZeneca
Merck
Lynparza
pancreatic cancer
FDA
advisory panels
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