In an unprecedented decision, the DC District Court temporarily grants an attorneys motion to keep his identity secret in connection with a form FDA-4...
FDA approves a Braeburn Inc. NDA for Brixadi (buprenorphine) extended-release injection (subcutaneous) for treating moderate to severe opioid use diso...
Abbott reports new data from an IDE study of its AVEIR dual-chamber i2i leadless pacemaker, described as the worlds first.
Rep. Chip Roy (R-TX) reintroduces the Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act that would expedite FDAs approval pro...
FDA approves an Entasis Therapeutics NDA for Xacduro (sulbactam and durlobactam for injection), a new treatment for hospital-acquired bacterial pneumo...
FDA agrees to a PolyPid Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal colorectal surgical sit...
FDA denies a Public Citizen petition that sought a Boxed Warning for all sodium-glucose cotransporter-2 inhibitor drugs contraindicating their use in ...
FDA updates its CDRH Portal to allow users to track the progress of pre-submissions for obtaining feedback on potential marketing applications.
