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Travere Filing sNDA for Filspari Full Approval

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Travere Therapeutics says confirmatory trial data for accelerated approval therapy Filspari (sparsentan) will form the basis of a ...

Guidance on ISO-10993-1 Explained

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Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international standard for medical device bio...

Ozempic Mental Health Issues Up: NPR

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An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide dru...

Merck sBLA for Keytruda Use in Cervical Cancer

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam r...

Orphan Drug Designation for Pumas Alisertib

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FDA grants orphan drug designation to Puma Biotechnologys small cell lung cancer investigative drug aliserib.

Comments Reopened on Opioid Disposal

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Federal Register notice: FDA reopens the comment period for the 4/4 notice entitled In-Home Disposal Systems for Opioid Analgesics...

FDA Dismisses Novo Nordisk Inspection Concerns

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In an unusual move, FDA issues a statement about recent agency inspections at Novo Nordisks Clayton, NC manufacturing facility to ...

Emergency Clinical Trial Conduct Guidance

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Federal Register notice: FDA makes available a final guidance entitled Considerations for the Conduct of Clinical Trials of Medica...

MicroVention Transradial Access Catheter Cleared

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FDA grants Terumos MicroVention unit 510(k) clearance for its SOFIA EX 5F 115 cm intracranial support catheter for transradial acc...

Major Disruption Clinical Trial Guidance

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FDA publishes a guidance to assist those involved with clinical trials in determining how to proceed during a disaster or public h...