Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy, achieved statist...
The CDER Accelerating Rare Disease Cures program Year-Three report shows a decline in new drug approvals and several other activities when compared wi...
The American Hospital Association suggests ways for FDA to develop a regulatory framework for measuring and evaluating AI-enabled medical devices.
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 ...
