FDA awards Eli Lilly traditional approval for Jaypirca (pirtobrutinib) and its use in adults with relapsed or refractory chronic lymphocytic leukemia ...
Veristat principal regulatory specialist John Kirk outlines FDAs Commissioners National Priority Voucher program and how sponsors can succeed with the...
FDA names physicianepidemiologist Tracy Beth Heg as CDER acting director, replacing director Richard Pazdur, who submitted his retirement paperwork ea...
A dozen former FDA commissioners warn that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evidence-based vaccine ...
FDA warns Provo, UT-based Rhyz Analytical Labs about CGMP violations in its work as a contract testing laboratory.
FDA warns Conway, AR-based Turbare Manufacturing about CGMP and other violations in its work as an outsourcing facility producing sterile drug product...
FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related information in the labeling...
A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its drug Sezaby, the first ...
