In a Time interview, president-elect Donald Trump said it has always been his commitment to preserve access to abortion pills, but also said the issue...
The Association for Accessible Medicines urges Congress to pass pending legislation to allow FDA to disclose sameness information about a brand drug t...
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Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.
