FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.
A Maryland federal judge dismisses a physician’s bid to force FDA to create a special, conditional access pathway for certain experimental Alzheimer’s treatments.
FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.
A Maryland federal judge dismisses a physician’s bid to force FDA to create a special, conditional access pathway for certain experimental Alzheimer’s treatments.
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 respiratory syncytial virus.
