Eton Pharmaceuticals files an NDA for zonisamide oral suspension for treating partial seizures in patients with epilepsy.
FDA seeks comment on a proposal to add four bulk drug substances to the bulk list for drug compounders.
FDA grants Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patients with higher-risk m...
Federal Register notice: FDA makes available a draft guidance entitled Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescripti...
FDA reminds patients, caregivers, and healthcare providers about the risks associated with deep brain stimulation devices when used to treat Parkinson...
FDA says its next Webinar on respirators and other personal protective equipment will be on 8/4.
FDA approves the Roche Ventana diagnostic assay to detect the HER2 biomarker in breast cancer and help determine candidates for the companys Herceptin...
Federal Register notice: FDA seeks comments on an information collection extension for additional criteria and procedures for classifying over-the-cou...