advisory panels

Rejected: After paying $80M to acquire it, Mallinckrodt’s jaundice drug snubbed by FDA’s advisory committee
Rejected: After paying $80M to acquire it, Mallinckrodt’s jaundice drug snubbed by FDA’s advisory committee
Endpoints
Mallinckrodt
FDA
advisory panels
infantile jaundice
InfaCare
stannsoporfin
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FDA Panel Splits on Lilly Arthritis Drug, Backs Lower of Two Doses
FDA Panel Splits on Lilly Arthritis Drug, Backs Lower of Two Doses
Xconomy
Eli Lilly
FDA
advisory panels
rheumatoid arthritis
baricitinib
Incyte
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FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy
FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy
Forbes
FDA
GW Pharma
Epidiolex
epilepsy
advisory panels
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Pfizer Gets FDA Panel Backing for New Indication for Xeljanz
Pfizer Gets FDA Panel Backing for New Indication for Xeljanz
Yahoo/Zacks.com
Pfizer
FDA
advisory panels
Xeljanz
ulcerative colitis
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FDA advisory group rejects Pacira’s pitch for expanded use of pain drug
FDA advisory group rejects Pacira’s pitch for expanded use of pain drug
Endpoints
FDA
advisory panels
Pacira
pain block
anesthesia
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Aradigm crashes after FDA panel votes down antibiotic
Aradigm crashes after FDA panel votes down antibiotic
Fierce Biotech
Aradigm
FDA
advisory panels
antibiotics
Linhaliq
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Why an FDA Panel Shot Down Intrinsic's Spinal Implant
Why an FDA Panel Shot Down Intrinsic's Spinal Implant
Medical Devices and Diagnostics Industry
FDA
advisory panels
devices
Intrinsic Therapeutics
spinal implants
Barracaid
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FDA panel votes yes on Indivior’s opioid addiction drug
FDA panel votes yes on Indivior’s opioid addiction drug
Endpoints
FDA
advisory panels
Indivior
opioid addiction
RBP-6000
buprenorphine
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FDA advisory committee backs Aerie’s Rhopressa eye drug
FDA advisory committee backs Aerie’s Rhopressa eye drug
Drug Delivery Business News
Aerie Pharma
Rhopressa
FDA
Open-Angle Glaucoma
ocular hypertension
advisory panels
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Spark’s Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote
Spark’s Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote
Xconomy
Spark Therapeutics
gene therapy
FDA
advisory panels
Luxturna
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J&J set back by negative panel vote for sirukumab
J&J set back by negative panel vote for sirukumab
BioPharma Dive
JNJ
FDA
sirukumab
advisory panels
rheumatoid arthritis
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Data supports safety of Dynavax hepatitis B vaccine -U.S. FDA panel
Data supports safety of Dynavax hepatitis B vaccine -U.S. FDA panel
Yahoo/Reuters
Dynavax
vaccines
hepatitis B
Heplisav
FDA
advisory panels
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Novartis wins unanimous support from FDA panel on groundbreaking CAR-T med
Novartis wins unanimous support from FDA panel on groundbreaking CAR-T med
Fierce Pharma
Novartis
CAR-T
FDA
advisory panels
CTL019
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FDA panel to focus on safety of Novartis gene therapy drug
FDA panel to focus on safety of Novartis gene therapy drug
Yahoo/Reuters
FDA
advisory panels
Novartis
gene therapy
CAR-T
acute lymphoblastic leukemia
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FDA panel supports cardiovascular indication for Novo’s diabetes drug Victoza
FDA panel supports cardiovascular indication for Novo’s diabetes drug Victoza
Fierce Pharma
FDA
advisory panels
Novo Nordisk
diabetes
Victoza
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July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
Endpoints
Novartis
FDA
CAR-T
advisory panels
CTL019
pediatric B-cell acute lymphoblastic leukemia
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FDA panel backs Pfizer biosim to blockbuster anemia meds from Amgen, Johnson & Johnson
FDA panel backs Pfizer biosim to blockbuster anemia meds from Amgen, Johnson & Johnson
Fierce Pharma
FDA
advisory panels
Pfizer
biosimilars
Amgen
Epogen
Procrit
anemia
JNJ
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FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug
FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug
Forbes
FDA
Puma Biotechnology
breast cancer
advisory panels
neratinib
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Pfizer's Epogen biosim scores solid backing from FDA staff ahead of panel review
Pfizer's Epogen biosim scores solid backing from FDA staff ahead of panel review
Fierce Pharma
Pfizer
Epogen
biosimilars
FDA
advisory panels
Amgen
anemia
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Puma Biotechnology FDA Live Blog
Puma Biotechnology FDA Live Blog
Forbes
FDA
Puma Biotechnology
advisory panels
neratinib
breast cancer
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