Attorney Grant Hollingsworth outlines Trump administration changes that could positively or negatively affect a preemption defense in drug and medical...
FDA cites significant data integrity and quality control failures at an Indian manufacturing facility operated by Aurobindo Pharma that was inspected ...
FDA accepts the Sibel Aria cough sensor into its Drug Development Tool qualification program.
FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.
A Maryland federal judge dismisses a physicians bid to force FDA to create a special, conditional access pathway for certain experimental Alzheimers t...
FDA accepts for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis.
CDER acting director Tracy Beth Hoeg says the Center is preparing new safety reviews of widely used antidepressants and monoclonal antibodies for resp...
Hyloris Pharmaceuticals says a recent FDA inspection of its Greek manufacturing partner resulted in an Official Action Indicated designation that coul...
