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FDA Accepts Anacor NDA for Nail Fungus Topical Drug

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FDA accepts for review an Anacor Pharmaceuticals NDA for tavaborole, an investigational drug for topically treating onychomycosis ...

Nurelin Meets Trial Endpoint

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Adamas Pharmaceuticals says its Nurelin met its primary endpoint in a Phase 2/3 trial in treating levodopa-induced Dyskinesia in P...

Panel to Hear Retrovirus, Immunoregulation Research

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/13 to hear an overview of r...

FDA Clears StemCells IND for Spinal Cord Injury

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FDA approves a StemCells, Inc. IND application for clinical testing of its HuCNS-SC human neural stem cells for treating chronic s...

Hospira Recalls Drugs Due to Glass Strands

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In its fifth GMP-related recall since May 1, Hospira recalls one lot of metoclopramide injection and two lots of ondansetron injec...

Forest Sues Generic Company Over Savella ANDA

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Forest Laboratories and Royalty Pharma Collection Trust jointly file a lawsuit in Delaware federal court against First Time U.S. G...

FDA Continues Delaying Action on Zogenix Zohydro

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FDA tells Zogenix there will be another short delay before it issues an action letter on the companys NDA for Zohydro ER.

Advisors to Consider Relistor sNDA

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FDA schedules an advisory committee meeting for March 2014 on a Salix sNDA for a broadened indication for Relistor.

Consider ANDA Petitions Carefully: Attorney

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Attorney Bruce Manheim raises issues companies should resolve when considering a citizen petition or lawsuit against FDA over a ge...

15 Medtronic MiniMed QS, MDR Violations Noted

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FDA releases a 15-violation Warning Letter it sent to Medtronic MiniMed about Quality System and Medical Device Reporting violatio...