Federal Register notice: FDA corrects a 7/13/2022 notice that announced the regulatory review period determination for Genentechs Enspryng (satralizum...
Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should address the use of exter...
FDA grants Orlucent a breakthrough device designation for the companys Orlucent Skin Fluorescence Imaging System.
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...
