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...
FDA warns Mumbai, India-based Kilitch Healthcare India about CGMP violations in its production of sterile ophthalmic drug products.
FDA warns Jiangsu, China-based Jiangsu Meifan Biotechnology Co. about CGMP violations in the production of finished OTC drugs found in an agency revie...
FDA grants Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell lung cancer with di...
