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J&J Impella Heart Pumps Get Expanded Indications

[ Price : $8.95]

FDA approves a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella ...

Pfizer Reports Favorable Ibrance Breast Cancer Data

[ Price : $8.95]

Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-li...

Fresenius Kabi Pump Early Alert

[ Price : $8.95]

CDRH issues an early alert on a Fresenius Kabi high-risk Ivenix large-volume pump issue, the Centers first alert under a new commu...

Stakeholders Comment on Patient Preference Guide

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Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total pro...

Furosemide Injection sNDA Faces Submission Delay

[ Price : $8.95]

scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor u...

FDA Science Board Renewed for 2 Years

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Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.

CDER Wants AI Use in Drug Safety: Attorneys

[ Price : $8.95]

Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.

Advisory Panel to Discuss Pediatric RSV Vaccine Safety

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FDA plans to ask its Vaccines and Related Biological Products Advisory Committee to discuss potential safety concerns related to p...

NIH Ends Mpox Study Early

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The National Institutes of Health ends a trial of an mpox antiviral drug that failed to produce an efficacy signal.