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Enhanced Coronary Lithotripsy Catheter OKd

[ Price : $8.95]

FDA approves a Shockwave Medical PMA for what the company calls an enhanced Shockwave C2+ Coronary Intravascular Lithotripsy cathe...

Regenerative Therapy Consensus Standards Guide

[ Price : $8.95]

Federal Register notice: FDA releases a final guidance entitled Voluntary Consensus Standards Recognition Program for Regenerative...

Pfizer Pentavalent Meningococcal Vaccine Approved

[ Price : $8.95]

FDA approves Pfizers Penbraya (meningococcal groups A, B, C, W and Y vaccine), a pentavalent vaccine that protects against the mos...

Philips Respironics Recalls V60 Ventilators

[ Price : $8.95]

Philips Respironics recalls its V60 Ventilators and V60 Plus Ventilators because the devices contain power management printed circ...

Arrest Made in Misbranded Device Case

[ Price : $8.95]

The U.S. government arrests a Chinese citizen related to a criminal complaint about manufacturing and distributing misbranded medi...

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...