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advisory panels

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

advisory panels

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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

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

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

advisory panels

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

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

Lexicon Pharmaceuticals

type 1 diabetes

advisory panels

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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

advisory panels

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Naloxone Availability: FDA Meeting Next Week

Naloxone Availability: FDA Meeting Next Week

RAPS.org

advisory panels

opioid overdose

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FDA advisory panel to mull transvaginal mesh

FDA advisory panel to mull transvaginal mesh

Mass Device

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

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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