FDA launches the CDER Center for Real-World Evidence Innovation with four areas of initial focus.
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Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.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.
