FDA clears a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce elevated intraocula...
Attorney Keeley McCarty says a recent government suit against Promothesus Group demonstrates the government is willing to use the False Claims Act to ...
FDA warns Los Angeles, CA-based DSP Skin Care about CGMP and other violations, some repeated from 2018, in its manufacturing of finished drugs.
Allarity Therapeutics says it is no longer economically feasible to pursue its dovitinib as a monotherapy for some renal cancers and it is refocusing ...
FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE studies through the adve...
Federal Register notice: FDA makes available a final guidance entitled Policy Regarding N-acetyl-L-cysteine.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Rozlytrek tablets (entrectinib).
Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an approved or pending drug...
