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Breakthrough Status for Bone Regeneration Product

[ Price : $8.95]

FDA grants Amphix Bio a breakthrough device designation for its drug-device combination product for bone regeneration.

Opdivo Approved for Resectable Lung Cancer

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment o...

FDA Denies Amneal Levothyroxine Petition

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FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provells Euthyrox (levothyroxine...

OrthAligns Lantern Hip Handheld Naviation Cleared

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FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in t...

Aldeyra Refiles NDA for Dry Eye Disease

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Aldeyra Therapeutics resubmits an NDA for topical ocular reproxalap, an investigational new drug for treating signs and symptoms o...

Changes Sought in Device Essential Outputs Guide

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Four stakeholders ask for clarifications and revisions in an FDA draft guidance on essential drug delivery outputs for devices int...

Philips Respironics Software Correction Class 1: FDA

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FDA says a Philips Respironics software correction for several ventilators was a Class 1 recall.

7 Observations in Annovex Pharma FDA-483

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FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsou...

GE Myocardial Perfusion Imaging Agent OKd

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FDA approves GE HealthCares Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging age...

Siemens PMA for 3D Mammography Platform OKd

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FDA approves a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging technology for its Mammomat B.br...