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Micro Therapeutics Recalls Embolization Device

[ Price : $8.95]

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...

Opportunities for Drug Development Dynamic Tools

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FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.

2 FDA Designations for Phantom Neuro Platform

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FDA approves both Breakthrough Device and Targeted Acceleration Pathway designations for Phantom Neuros Phantom X platform that co...

Makary Pledges FDA Staff Assessment Due to Firings

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FDA commissioner-nominee Marty Makary pledges during his confirmation hearing to do an independent assessment on personnel before ...

Baxter Infusion Pump Issue Early Alert

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FDA issues a medical device early alert on a Baxter recall of specified Spectrum infusion pumps.

DOGE-Targeted FDA Lab to Remain Open

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The Trump Administration reverses an Elon Musk decision to terminate the lease of a 52,000 square foot major FDA laboratory in St....

Orphan Drug Designation for Farons Bexmarilimab

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FDA grants orphan drug designation to Farons bexmarilimab to treat myelodysplastic syndrome.

Roche Files sBLA for Gazyva in Lupus

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FDA accepts for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis.

Indian-Made Generics Have Higher Risk: Study

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An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with se...