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DNAtrix Gets Orphan Drug for Malignant Glioma

[ Price : $8.95]

FDA grants orphan drug status to DNAtrix for DNX-2401 for treating malignant glioma.

FDA Approves Salix Pharmas Ulcerative Colitis Drug

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FDA approves Salix Pharmaceuticals Uceris (budesonide) rectal foam, indicated for inducing remission in patients with active mild-...

FDA Co-hosting Cybersecurity Meeting

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CDRHs Suzanne Schwartz outlines several steps FDA is taking to increase cybersecurity for medical devices.

Genentech Files sBLA for Lucentis

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FDA accepts for priority review a Genentech supplemental BLA for Lucentis (ranibizumab injection) for treating diabetic retinopath...

Hospira Recalls One Vancomycin Lot

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Hospira recalls one lot of vancomycin hydrochloride for injection because the product may have experienced temperature excursions ...

SAM Medical Recalls Tourniquet Accessory Clip

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SAM Medical Products recalls clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniq...

OMB OKs Info on Classifying OTC Drugs as GRASE

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Federal Register Notice: The Office of Management and Budget approves a collection of information on additional criteria and proce...

Guidance on OTC Pediatric Liquids with Acetaminophen

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Federal Register Notice: FDA releases a draft guidance: Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

FDA Science Board to Meet

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Federal Register Notice: The Science Board to FDA will meet 11/19-20 to discuss, among other topics, anesthetics and sedation drug...

Drug Umbrella Names Lead to Confusion: ISMP

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The Institute for Safe Medication Practices calls for regulatory changes to require that products given an umbrella name contain a...