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CDER says FY 2019 User Fee Program Fee invoices were emailed 8/15 with a 10/1 due date for the $309,915 fee.[ Price : $8.95]
A Center for Science and Democracy survey of FDA scientists praises agency leaders while raising some concerns about political and...[ Price : $8.95]
FDA accepts for review an Evoke Pharma 505(b)(2) NDA for Gimoti, a nasal spray product candidate for relieving symptoms in adult w...[ Price : $8.95]
FDA approves Sun Pharmaceutical Industries Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production i...[ Price : $8.95]
Endo resumes its suit challenging FDAs interim policy on drug compounding and seeking removal of vasopressin from Category 1 nomin...[ Price : $8.95]
FDA approves Eisai and Mercks kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hep...[ Price : $8.95]
Two pharmaceutical trade associations suggest changes to a draft antibiotic limited population pathway guidance.[ Price : $8.95]
Federal Register notice: FDA issued a priority review voucher to Ultragenyx Pharmaceutical for its approved rare pediatric disease...