The CDER Office of New Drugs suggests a way that Agile Therapeutics can proceed with its Twirla contraceptive patch that received a 2017 complete resp...
FDA clears Eximo Medical 510(k) for the B-Laser Atherectomy System for treating peripheral artery disease.
Federal Register notice: FDA announces an 11/15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss the assessment of opioid ...
FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA System and the risks associat...
FDA accepts for review a Novartis NDA for once-daily siponimod (BAF312) for treating secondary progressive multiple sclerosis in adults.
FDA approves an Akcea Therapeutics and Ionis Pharmaceuticals NDA for Tegsedi (inotersen) for treating polyneuropathy of hereditary transthyretin-media...
FDA accepts for priority review a Karyopharm Therapeutics NDA that is seeking accelerated approval for selinexor, an oral SINE compound indicated for ...
FDA tentatively approves an Ortho Dermatologics NDA for Bryhali (halobetasol propionate) lotion for the topical treatment of plaque psoriasis in adult...