FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.
Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease product application...
Par Pharmaceutical asks a court to stop FDA from granting final approval to a BPI epinephrine product that cites a Par product as the reference-listed...
FDA asks the Oncologic Drugs Advisory Committee to consider whether minimal residual disease is an appropriate intermediate clinical endpoint to suppo...
A new National Academies report calls on FDA and other federal government entities to take steps to increase the participation of pregnant and lactati...
In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency issues an import alert against Jiangsu S...
Two stakeholders comment positively on an FDA public meeting on advancing the use of complex innovative designs in clinical trials.
CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare providers may help them for...
