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Top biopharmadive.com News

FDA's Top Drug Regulator Resigns After Federal Officials Probe 'Serious Concerns' — REUTERS / pwu404

FDA · United States

FDA's Top Drug Regulator Resigns After Federal Officials Probe 'Serious Concerns'

60% Center coverage: 70 sources

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday amid concerns about his personal conduct See the Story

Novo Nordisk hikes Metsera bid to up to $10B in competition with rival Pfizer — REUTERS / pwu404

Novo Nordisk · Denmark

Novo Nordisk hikes Metsera bid to up to $10B in competition with rival Pfizer

Coverage: 14 sources

FDA's Rigid Approach Adds Uncertainty To uniQure's Accelerated Pathway For Huntington's Gene Therapy - uniQure (NASDAQ:QURE)

FDA · United States

FDA's Rigid Approach Adds Uncertainty To uniQure's Accelerated Pathway For Huntington's Gene Therapy - uniQure (NASDAQ:QURE)

83% Center coverage: 6 sources

The U.S. Food and Drug Administration (FDA) on Monday provided feedback to uniQure N.V. (NASDAQ:QURE) regarding its investigational gene therapy for Huntington's disease. QURE is among today's weakest performers. Stay ahead of the curve here uniQure believes that the FDA currently disagrees that the data from the Phase 1/2 studies of AMT-130, in comparison to an external control, as per the prespecified protocols and statistical analysis plans …See the Story

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