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FDA Clears NKGen IND for Alzheimers Cell Therapy

[ Price : $8.95]

FDA clears an NK Gen IND trial for its Alzheimers disease cell therapy.

Zhimeng Bio Gets Orphan Status for ALS Drug

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FDA grants Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (C...

Medtronic PMA for Extravascular ICD Approved

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FDA approves a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila ...

Genentechs Rozlytrek Gets Expanded Use

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FDA grants Genentech accelerated approval for an expanded use for Rozlytrek (entrectinib) in treating pediatric patients older tha...

Fresenius Recalls Some Hemodialysis Machines

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Fresenius Medical Care recalls some of its 2008 Series Hemodialysis Machines because patients may be exposed to toxic compounds th...

Guide on Scientific Info on Unapproved Uses

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FDA posts a revised draft guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on...

Generic Animal Drug User Fee Rates

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FDA sets the rates and payment procedures for fiscal year 2024 generic new animal drug program user fees.

FDA Sets Animal Drug User Fee Rates

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Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2024 animal drug user fees.

FDA Approves Zymfentra as Maintenance Therapy

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FDA approves a Celltrion BLA for Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ...

Panacea Biotec Gets 9-item FDA-483

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FDA issues Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firms Himachal Pradesh, India manufacturing 10/3-12...