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advisory panels

With FDA Panel’s Nod, First Postpartum Depression Drug Nears Approval

With FDA Panel’s Nod, First Postpartum Depression Drug Nears Approval

Xconomy

advisory panels

SAGE Therapeutics

postpartum depression

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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

advisory panels

major depressive disorder

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FDA advisers back Shire constipation drug

FDA advisers back Shire constipation drug

Pharmaforum

advisory panels

chronic idiopathic constipation

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Advisory panel narrowly rejects oliceridine for acute pain

Advisory panel narrowly rejects oliceridine for acute pain

BioCentury

advisory panels

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FDA panel unanimously backs Celltrion's Rituxan biosimilar

FDA panel unanimously backs Celltrion's Rituxan biosimilar

Fierce Pharma

Teva Pharmaceutical

advisory panels

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Trevena shares sink on FDA concerns ahead of key panel meeting

Trevena shares sink on FDA concerns ahead of key panel meeting

Biopharma Dive

advisory panels

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FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote

FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote

Fierce Pharma

advisory panels

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Paratek clears one last big hurdle on the way to an FDA marketing decision for antibiotic

Paratek clears one last big hurdle on the way to an FDA marketing decision for antibiotic

Endpoints

advisory panels

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FDA advisory panel turns down PneumRx’s Elevair lung implant

FDA advisory panel turns down PneumRx’s Elevair lung implant

Fierce Biotech

advisory panels

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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

advisory panels

infantile jaundice

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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

advisory panels

rheumatoid arthritis

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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

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

advisory panels

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

advisory panels

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Aradigm crashes after FDA panel votes down antibiotic

Aradigm crashes after FDA panel votes down antibiotic

Fierce Biotech

advisory panels

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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

advisory panels

Intrinsic Therapeutics

spinal implants

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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

advisory panels

opioid addiction

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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

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

advisory panels

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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

advisory panels

rheumatoid arthritis

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