FDA approves a Deciphera Pharmaceuticals NDA for Qinlock (ripretinib) tablets as a fourth-line treatment for advanced gastrointestinal stromal tumor.
FDA issues Blueprint Medicines a complete response letter for its NDA for avapritinib, indicated for treating adults with unresectable or metastatic f...
FDA denies a petition seeking to delay agency development of a memorandum of understanding with states on regulating drug compounding
Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic Products.
Federal Register notice: FDA sends to OMB an information collection revision for Human Drug Compounding Under Sections 503A and 503B of the Federal Fo...
FDA updates a guidance to explain how sterile compounded drugs can be prepared in a segregated compounding area if standard personal protective equipm...
FDA posts a Web resource page on using thermal imaging systems for temperature screening during Covid-19.
FDA warns Ideal Implants about QS and MDR violations in its manufacturing of saline-filled breast implants.