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Novocure Phase 3 Study Misses Primary Endpoint

[ Price : $8.95]

Novocure says its Phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 clinical trial of Tumor Treating Fields together with paclitaxel in patie...

Final Guide on Product Tracing Enforcement

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Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security Requirements Under Sect...

Enforcement Deferred on Drug Security Needs

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FDA posts a guidance on new enforcement deferments affecting enhanced drug distribution security requirements.

Inmar Recalls Products Due to Rodent Infestation

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Inmar Supply Chain Solutions recalls FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, di...

Comments Sought on Pepaxtos Proposed Withdrawal

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CDER asks for comments on its proposal to withdraw Oncopeptides accelerated-approved multiple myeloma drug Pepaxto (melphalan fluf...

CDRH Qualifies Tool on Material Biostability

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CDRH announces the qualification of a new tool through the agencys voluntary Medical Device Development Tools program: Accelerated...

Fresenius Home Hemodialysis Guide Cleared

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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...