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23 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they are no longer marketed.

FDA Launches Home as a Healthcare Hub

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FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healthcare providers, and industry....

New Bladder Cancer Therapy Approved

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FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Gurin (BCG) for treating pa...

Sail Fusion Sacroiliac Fusion Device Cleared

[ Price : $8.95]

FDA clears a Sail Fusion 510(k) for its BowTie Sacroiliac Fusion System.

Pediatric Brain Tumor Therapy Approved

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FDA grants Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients ...

Exactech Recalls Equinoxe Shoulder Devices

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Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities unused inventory.

FDA Warns on OTC Anti-choking Devices

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FDA warns against the use of over-the-counter anti-choking devices because they are not approved or cleared by the agency.

Royal Philips Zenition 30 Imager Cleared

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FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.

Panel to Review Colon Cancer Blood Test

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FDA announces that its Medical Devices Advisory Committees Molecular and Clinical Genetics Panel is scheduled to review a Guardant...

Complete Response' on Abeonas PZ-Cel BLA

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FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional inf...