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Concerns with Macular Degeneration Guidance

[ Price : $8.95]

A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing ...

Iovance Bio Gets Priority Review for Melanoma BLA

[ Price : $8.95]

FDA accepts for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy ...

Janssen NDA for Pulmonary Hypertension Drug

[ Price : $8.95]

Janssen submits an NDA to FDA for an investigational combination of Opsumit and Cialis to treat some adults with pulmonary arteria...

Think Surgical Gains Clearance for TMINI Robot

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FDA clears a Think Surgical 510(k) for its TMINI Miniature Robotic System for performing total knee replacement surgeries.

Guide on Power Morcellator Tissue Containment

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Federal Register notice: FDA makes available a final guidance entitled Non-Clinical Performance Assessment of Tissue Containment S...

Pfizers Marstacimab Meets Phase 3 Goals

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Pfizer says its hemophilia drug marstacimab met the primary endpoints in the Phase 3 BASIS trial.

Akebia Therapeutics Resubmitting Anemia NDA

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CDERs Office of New Drugs denies an Akebia Therapeutics dispute resolution request following receipt of a 3/22 complete response l...

Suggestions for Oncology Accelerated Approval Guidance

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Two stakeholders make recommendations for improving an FDA draft guidance on clinical trial considerations to support accelerated ...

iRhythm Gets Warning Letter on Heart Monitor

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FDA sends iRhythm Technologies a Warning Letter that cites violations from an 8/22 agency inspection of the companys Zio heart mon...

Guide on Diabetes Trial Endpoints

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Federal Register notice: FDA releases a draft guidance entitled Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investig...