A new Bloomberg report finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential expanded approval of...
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 issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that impro...
provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use of them significantly...
The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio misleadingly creates the im...
