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FDA approves a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella ...[ Price : $8.95]
Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-li...[ 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...[ Price : $8.95]
Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total pro...[ Price : $8.95]
scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor u...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.[ Price : $8.95]
Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.