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...
FDA Review posts the Federal Register notices for the week ending 10/5/2018.
Federal Register notice: FDA announces an 11/14 joint advisory committee meeting to discuss a SpecGx NDA for its abuse-deterrent pain drug.
FDA grants MediciNova an orphan-drug designation for MN-166 (ibudilast) as adjunctive therapy to chemotherapy drug temozolomide for treating glioblast...
Congress fails to secure passage of an FDA spending bill last week and it is looking very likely that the agencys funding will be covered by a Continu...