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Panel to Discuss Opioid Analgesic Sparing Outcomes

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Federal Register notice: FDA announces an 11/15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss the a...

Class 1 Recall for Endologix Safety Notice

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FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA System an...

Novartis NDA Accepted for Multiple Sclerosis Drug

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FDA accepts for review a Novartis NDA for once-daily siponimod (BAF312) for treating secondary progressive multiple sclerosis in a...

Karyopharm Therapeutics NDA for Multiple Myeloma

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FDA accepts for priority review a Karyopharm Therapeutics NDA that is seeking accelerated approval for selinexor, an oral SINE com...

FDA Tentatively Approves Orthos Psoriasis Lotion

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FDA tentatively approves an Ortho Dermatologics NDA for Bryhali (halobetasol propionate) lotion for the topical treatment of plaqu...

FDA OKs Akcea Therapeutics/Ionis Pharmaceuticals Drug

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FDA approves an Akcea Therapeutics and Ionis Pharmaceuticals NDA for Tegsedi (inotersen) for treating polyneuropathy of hereditary...

Joint Panel to Review Abuse-deterrent Pain Drug

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Federal Register notice: FDA announces an 11/14 joint advisory committee meeting to discuss a SpecGx NDA for its abuse-deterrent p...

Orphan Status for MediciNova Glioblastoma Drug

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FDA grants MediciNova an orphan-drug designation for MN-166 (ibudilast) as adjunctive therapy to chemotherapy drug temozolomide fo...

FDA Funding to be Covered by Continuing Resolution

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Congress fails to secure passage of an FDA spending bill last week and it is looking very likely that the agencys funding will be ...

De Novo Clearance of Bose Hearing Aid

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FDA allows the de novo marketing of Bose Corp.s Bose Hearing Aid, the first hearing aid that enables users to fit, program and con...