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Plus Therapeutics Gets Orphan Statis for Radiotherapy

[ Price : $8.95]

FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal...

FDA Denys Hearing on Vanda Hetlioz Rejection

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Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Va...

J&J Stops Phase 3 Depression Drug Program

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Johnson & Johnson stops its Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depress...

FDA Domestic Inspections Fall, Foreign Rise: Study

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Consultants from Eliquent Life Sciences say most of FDAs drug inspection-based Warning Letters issued in fiscal year 2024 went to ...

Celltrion BLA for Interchangeable Xolair Biosimilar

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FDA approves a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentechs Xolair (omalizumab).

FDA Nixes Vanda Hetlioz Hearing

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FDA denies a hearing on Vandas Hetlioz sNDA and proceeds with its rejection of the filing.

Nuwellis AquaFlexFlow Recall is Class 1

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FDA says a Nuwellis 12/2024 recall of certain lots of its extracorporeal blood circuits is Class 1.

FDA OKs Gene Therapy for Retinal Disease

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FDA approves a Neurotech Pharmaceuticals BLA for Encelto (revakinagene taroretcel-lwey) for treating macular telangiectasia Type 2...

Micro Therapeutics Recalls Embolization Device

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Medtronics Micro Therapeutics unit recalls its Pipeline Vantage Embolization Device with Shield Technology after it determined tha...

FDA OKs Expanded Use of Furoscix

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FDA approves a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the indication to include treatmen...