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...
FDA denies an Alliance for Natural Health citizen petition urging the agency to require all makers of proton pump inhibitors to expand the existing la...
FDA sends contract testing laboratory Sure-Biochem Laboratories a Warning Letter after a 10/2022 inspection cited significant GMP violations associate...
