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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company HealthQuilt.

FDA Accepts Oyster Point Pharma Dry Eye NDA

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FDA accepts an Oyster Point Pharma NDA for its OC-01 nasal spray to treat signs and symptoms of dry eye disease.

Eyenovia NDA for Pupil Dilation Drug

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FDA accepts for review an Eyenovia NDA for MydCombi (tropicamide 1% and phenylephrine 2.5%) ophthalmic solution, a fixed combinati...

FDA Issues EUA for Janssen Covid Vaccine

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FDA issues an emergency use authorization to Janssen Biotech for its single intramuscular Covid-19 vaccine injection.

Class 1 Recall of Medtronic HVAD Pump Kit

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Medtronic conducts a Class 1 recall of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the device may fail...

New Rare Disease Efforts to Help Product Development

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FDA announces new actions to advance rare disease product development and approval.

FDA Issues Complete Response on CorMedix DefenCath

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FDA sends CorMedix a complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kid...

Merck NDA for Cough Drug Accepted for Review

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FDA accepts for review a Merck NDA for gefapixant, an investigational selective P2X3 receptor antagonist for treating refractory c...

Firms Ordered to Pay $834 Million Over Plavix Marketing

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A Hawaiian court orders Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries to pay $834 million to the state of Hawaii o...

FDA Turns Down Athenex Breast Cancer Drug

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FDA sends Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer d...