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FDA Diversity Plan Draft Guidance Due: RAPS

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A RAPS publication says FDA is likely to publish a draft guidance on plans for clinical trial diversity by the end of this year.

Hyperfines AI Brain Imaging Software Cleared

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FDA clears a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system.

Guide on Magnetic Resonance Diagnostics

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FDA posts a final guidance entitled Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.

FDA OKs Medtronics Next-Gen SynchroMed

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FDA approves Medtronics next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pai...

Positive Keytruda Data in Lung Cancer: Merck

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Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients wit...

18 FDA Info Collections Okd by OMB

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Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.

Companion Diagnostic for Retevmo Approved

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FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selp...

Alnylam Gets Complete Response on sNDA

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FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyo...

Biocon Gets Insulin Aspart BLA Rejection

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FDA issues Biocon Biologics a complete response letter on its BLA for insulin aspart.

Breakthrough Status for Knee Implant

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FDA grants ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to delay or elimin...