FDA publishes a draft guidance with information and recommendations to assist in developing drugs to prevent or treat acute radiation syndrome.
The National Cancer Institute says Syndax Pharmaceuticals revumenib shows promise in treating some acute myeloid leukemias.
FDA says drug compounders should be sure the active pharmaceutical ingredients and excipients they use have been evaluated by their suppliers for puri...
ProPublica says FDA foreign drug manufacturer inspections remain well below pre-pandemic inspection levels.
Sidley attorneys say a new FDA final guidance on a risk-based approach to clinical trial oversight is significant for trial sponsors.
Generic mifepristone maker GenBioPro sues FDA to block the agency from taking any actions against the company if a pending court order under review by...
FDA approves an expanded indication for AbbVies Qulipta to prevent chronic migraines.
The U.S. Supreme Court extends by two days (until 4/21) its administrative stay of a lower courts 4/7 order that would restrict the distribution of th...
