An IQVIA analysis of novel active substance approvals from 2014 to 2022 in the U.S., EU, and Japan shows the U.S. approves more new drugs and approves...
FDA approves a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist ...
Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-line maintenance thera...
CDRH issues an early alert on a Fresenius Kabi high-risk Ivenix large-volume pump issue, the Centers first alert under a new communications pilot prog...
Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.
scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor used with its Furosci...
Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.
Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.
