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FDA Accepts sNDA for Bowel Drug Gattex

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FDA accepts for review an NPS Pharmaceuticals supplemental NDA for Gattex (teduglutide [rDNA origin]) for injection, which is curr...

FDA Asks OTC Topical Antiseptic Label, Packaging Changes

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FDA asks manufacturers of certain OTC topical antiseptics to revise the products labels and packaging to help prevent infections i...

FDA Grants Mast Therapeutics Orphan Status for MST-188

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FDA grants Mast Therapeutics an orphan drug designation for MST-188 for treating acute limb ischemia.

FDA Says Sarepta NDA for Eteplirsen is Premature

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FDA tells Sarepta Therapeutics that its planned NDA filing is premature for eteplirsen and its use in treating Duchenne muscular d...

Reviewers Back Tasimelteon Approval

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CDER medical reviewers tell the Peripheral and Central Nervous System Advisory Committee that they recommend approval of Vanda Pha...

GSK Darapladib Trial Fails to Meet Endpoint

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GlaxoSmithKline says its darapladib failed to meet the primary endpoint in a Phase 3 trial of its use in adults with chronic coron...

Nautilus Asks Cambia PREA Deferral Reconsideration

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Nautilus asks FDA to reconsider its request for a deferral of pediatric studies of its migraine analgesic Cambia.

FDA Clears IntelligentMDx C. difficile Assay

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FDA clears an IntelligentMDx 510(k) for its IMDx C. difficile for use with Abbotts m2000 assay.

FDA Partnering with Mekong Region on Food, Drug Safety

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FDA commissioner Margaret Hamburg says her agency is working with Mekong Region counterparts on issues of food and drug safety.

FDA Gives Medicines Co. QIDP Designation for Antibiotic

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FDA gives the Medicines Co. a Qualified Infectious Disease Product designation for oritavancin and its use in treating acute bacte...