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Pharmacyclics sNDA for Imbruvica Submitted

[ Price : $8.95]

Pharmacyclics files a supplemental NDA for Imbruvica (ibrutinib) for front-line use in patients with chronic lymphocytic leukemia.

Public Meeting on Drug Interactions with Contraceptives

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Federal Register Notice: FDA plans a public meeting 11/9: Drug Interactions with Hormonal Contraceptives (HCs): Public Health and ...

FDA Accepts Dimension IND for Hemophilia Drug

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FDA accepts a Dimension Therapeutics IND for a clinical study to evaluate DTX101 in adult patients with moderate/severe to severe ...

Allergan Gains 3 Generic Mucinex Approvals

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Allergan gains FDA approval for three ANDAs for three generic Mucinex products.

Panel Votes Down New Purdue Painkiller

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FDAs Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee vote 23 to 1...

GPhA Says FDA Oversteps Authority on Tablet Size Concerns

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The Generic Pharmaceutical Association says FDA has no scientifically-supported safety or efficacy concern that would require it t...

Amgen sNDA for Repatha Single-dosing Option

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Amgen submits a supplemental NDA seeking approval for a single-dosing option for monthly administration of Repatha (evolocumab) In...

Fast Track Given to Aridis Monoclonal Antibody

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FDA grants Aridis Pharmaceuticals a fast track designation for AR-301, a fully human anti-Staphylococcal alpha-toxin IgG1 monoclon...

MediciNovas Tipelukast Gets Fast Track forFibrosis

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FDA grants fast track designation to MediciNova for its MN-001 (tipelukast) for treating patients with idiopathic pulmonary fibros...

FDA Accepts Theravance sNDA for Vibativ

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FDA accepts for review a Theravance Biopharma supplemental NDA for Vibativ (telavancin) seeking to expand the current label to inc...