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BioMarin Expanded Indication for Voxzogo

[ Price : $8.95]

FDA approves a BioMarin Pharmaceutical supplemental NDA for Voxzogo (vosoritide) to increase linear growth in pediatric patients w...

FDA Withdrawing 8 ANDAs

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Federal Register notice: FDA withdraws approval of eight ANDAs after the applicants notified the agency that they were no longer m...

FDA Updates AI/ML-Enabled Medical Device List

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FDA adds 171 devices to its list of AI/ML-enabled medical devices.

Untitled Letter for Indias Nectar Lifesciences

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FDA cautions Indias Nectar Lifesciences about CGMP violations in its production of finished drugs.

OCE Scientific Collaborative Research Areas

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The FDA Oncology Center of Excellence explains its OCE Scientific Collaborative regulatory research support efforts focused on nin...

Cardio Flow Orbital Atherectomy Device Cleared

[ Price : $8.95]

FDA clears a Cardio Flow510(k) for the companys FreedomFlow Orbital Atherectomy Peripheral Platform.

Final Guide on Remote Monitoring Devices

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devic...

2 Guides on Covid-19 Withdrawn

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Federal Register notice: FDA withdraws two guidances Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing...

Hygienic Labs Didnt Respond to FDA Data Requests

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FDA warns Denver, CO-based Hygienic Labs that it has not responded to multiple requests for records and information so the agency ...

BMS Seeking Approval of Subcutaneous Opdivo

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Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with ...