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Fresenius Home Hemodialysis Guide Cleared

[ Price : $8.95]

FDA clears a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the companys VersiHD chr...

Redx Orphan Status for Pulmonary Fibrosis

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FDA grants Redx an orphan drug designation for zelasudil (RXC007) for treating idiopathic pulmonary fibrosis.

FDA Updates HeartWare Device Alert

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Medtronic issues an Urgent Medical Device Communication about its HeartWare Ventricular Assist Device (HVAD) systems and a newly i...

Merck, Eisai Stop LEAP-010 Trial

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Merck and Eisai terminate the Phase 3 LEAP-010 trial evaluating Mercks Keytruda (pembrolizumab) plus Eisais Lenvima (lenvatinib) i...

Finalized Informed Consent Guidance Analyzed

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Ropes & Gray attorneys break down a new FDA final guidance on informed consent, highlighting changes from a previous draft.

FDA OKs New Veklury Covid Indication

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FDA approves a Gilead Veklury sNDA eliminating the need for dose adjustments when treating Covid-19 in patients with mild, moderat...

Akebia Plans 3rd Quarter Vadadustat NDA Resubmission

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Akebia Therapeutics says it plans to resubmit an NDA to FDA for vadadustat to treat anemia due to chronic kidney disease.

Fast Track for Abdominal Aneurysm Product

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FDA grants Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment combination product for ...

Paragonix Donor Lung Preservation Device Cleared

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FDA clears a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard.

More Drug Approval Transparency Needed: Studies

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Oregon State University says two research studies show that more drug approval transparency is needed.