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Emerging Drug Safety Technology Meeting Program

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FDA launches an Emerging Drug Safety Technology Meeting (EDSTM) program to assist industry in implementing artificial intelligence...

GSKs Arexvy Gets Expanded Approval

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FDA approves an expanded use for GSKs Arexvy (respiratory syncytial virus vaccine, adjuvanted) for preventing RSV lower respirator...

FDA Clears 2 Abbott OTC Glucose Monitors

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FDA clears two Abbott 510(k)s for over-the-counter continuous glucose monitoring systems Lingo and Libre Rio.

FDA Panel Backs Lillys Alzheimers Drug

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FDAs Peripheral and Central Nervous System Advisory Committee unanimously votes to recommend the approval of Eli Lillys donanemab-...

Moon Surgicals Maestro Surgical Device Cleared

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FDA clears a Moon Surgical 510(k) for its Maestro surgical system.

Geron Myelodysplastic Syndromes NDA Approved

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FDA approves a Geron NDA for Rytelo (imetelstat) for treating certain adult patients with low- to intermediate-1 risk myelodysplas...

CDER Proposes to Deny Vanda Hetlioz sNDA

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Federal Register notice: CDER posts a proposal to refuse the approval of a supplemental NDA submitted by Vanda Pharmaceuticals for...

Panel to Review Imfinzi sBLA in Lung Cancer

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Federal Register notice: FDA announces a 7/25 Oncologic Drugs Advisory Committee meeting to an AstraZeneca supplemental BLA for Im...

DePuy Synthes Gets 510(k) for Robotic Knee Device

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FDA clears a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.

Genetic Signatures GI Parasite Detector Cleared

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FDA clears a Genetic Signatures 510(k) for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow.