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Federal Register notice: FDA makes available two new product-specific draft guidances for submitting ANDAs for capsaicin and estra...[ Price : $8.95]
The CDER Office of New Drugs suggests a way that Agile Therapeutics can proceed with its Twirla contraceptive patch that received ...[ Price : $8.95]
FDA clears Eximo Medical 510(k) for the B-Laser Atherectomy System for treating peripheral artery disease.[ Price : $8.95]
Federal Register notice: FDA announces an 11/15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss the a...[ Price : $8.95]
FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA System an...[ Price : $8.95]
FDA accepts for review a Novartis NDA for once-daily siponimod (BAF312) for treating secondary progressive multiple sclerosis in a...[ Price : $8.95]
FDA accepts for priority review a Karyopharm Therapeutics NDA that is seeking accelerated approval for selinexor, an oral SINE com...[ Price : $8.95]
FDA tentatively approves an Ortho Dermatologics NDA for Bryhali (halobetasol propionate) lotion for the topical treatment of plaqu...