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Tentative OK for Perrigos Generic Skin Gel

[ Price : $8.95]

FDA tentatively approves a Perrigo ANDA for a generic version of Galderma Labs Mirvaso (brimonidine) topical gel 0.33%, indicated ...

Lilly Plans 2018 NDA for Migraine Drug After Trial Results

[ Price : $8.95]

Eli Lilly says its investigational migraine drug lasmiditan met its primary endpoint in SPARTAN, a second Phase 3 study of the the...

Orphan Status for Omeros Immunoglobulin A Nephropathy Drug

[ Price : $8.95]

FDA grants Omeros an orphan drug designation for OMS721 for treating Immunoglobulin A (IgA) nephropathy.

FDA Warning on Compounded Curcumin

[ Price : $8.95]

FDA warns healthcare professionals about hypersensitivity reactions related to ImprimisRxs curcumin (a component of the spice turm...

Consent Decree Entered Against Utah Drug Outsourcer

[ Price : $8.95]

A Utah federal judge enters a consent decree of permanent injunction against Isomeric Pharmacy Solutions (Salt Lake City), co-owne...

FDA Orphan Status for Vision Loss Gene Therapy

[ Price : $8.95]

FDA grants Applied Genetic Technologies an orphan drug designation for its unidentified gene therapy product candidate for treatin...

FDA Clears Bariatric Surgery Clamp

[ Price : $8.95]

FDA clears a Standard Bariatrics 510(k) for the Standard Clamp, a disposable laparoscopic surgical clamp that is intended to assis...

Why Tobacco Detracts from FDAs Budget Case

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Alliance for a Stronger FDA explains how tobacco user fees skew the case for raising taxpayer-funded budget levels for FDAs annual...

Daiichi Sankyo Settling Olmesartan Product Cases

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Daiichi Sankyo says that it and Forest are settling claims against them alleging their olmesartan products caused sprue-like enter...

Guide on Child-Resistant Packaging Statements

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Federal Register notice: FDA announces the availability of a draft guidance on Child-Resistant Packaging Statements in Drug Produc...