Vyaire Medical recalls its enFlow Fluid Warming System disposable cartridges due to the potential for aluminum to elute from the warmer into the fluid...
Durect submits a detailed reply to an FDA 2014 complete response letter for Posimir (bupivacaine extended-release solution), a post-operative pain rel...
The House/Senate Problem Solvers Caucus releases principles for supporting legislation to lower drug prices.
Federal Register notice: FDA makes available a draft guidance entitled Clinical Investigations for Prostate Tissue Ablation Devices.
The CDER Office of Prescription Drug Promotion wants to study the relationship between television disease awareness communications and prescription dr...
A U.S. Supreme Court decision makes it easier for FDA and other government agencies to shield companies supposed commercial/confidential information f...
FDA releases a list of 20 guidances it expects to work on during 2019.
FDA expands the approval of Regenerons Dupixent (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis.