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25 New and Revised ANDA Bioequivalence Draft Guides

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Federal Register notice: FDA makes available two new product-specific draft guidances for submitting ANDAs for capsaicin and estra...

FDA Offers Path Forward for Twirla NDA

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The CDER Office of New Drugs suggests a way that Agile Therapeutics can proceed with its Twirla contraceptive patch that received ...

Eximo Laser Cleared for Peripheral Artery Disease

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FDA clears Eximo Medical 510(k) for the B-Laser Atherectomy System for treating peripheral artery disease.

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...