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FDA Lifts Hold on Myotonic Dystrophy Drug

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FDA lifts a partial clinical hold on Avidity Biosciences delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for...

5 Observations on BSO FDA-483

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FDA has released the form FDA-483 with five observations from an inspection at the Lakewood, CO-based BSO outsourcing facility.

18 Potential Signals of Serious Risks/New Safety Info

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FDA releases a list of 18 drug products for which there was a potential signal of serious risks or new safety information in the s...

Breakthrough Status for Bone Regeneration Product

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Four stakeholders ask for clarifications and revisions in an FDA draft guidance on essential drug delivery outputs for devices int...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