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Forest and Gedeon Richter See Mixed Results for Antipsychotic

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Forest Laboratories and Gedeon Richter report mixed results from an exploratory Phase 2 trial involving the investigational antips...

FDA Extends Review of Eisai Breast Cancer NDA

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FDA extends by three months its review of an Eisai NDA for eribulin mesylate, indicated for treating locally advanced or metastati...

3 Former Spectranetics Execs Indicted

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A federal indictment accuses three former Spectranetics executives and a fourth person of multiple counts involved in illegally im...

Obama Change Agenda Comes to Nought

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FDA Webview editor Jim Dickinson reviews the Obama change agenda broadly and finds, from FDA to Afghanistan, that it has delivered...

New Cancer Drug Cocktail Rules Coming

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CDER oncology drugs director Richard Pazdur says the agency is working on new research guidelines to facilitate development of can...

FDA 'Orphan' Designation for Pompe Drug by BioMarin

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FDA grants BioMarin Pharmaceutical Inc. an orphan drug designation for BMN-701, an investigational drug under development for trea...

Guidance on Acute Bacterial Skin Functions

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Federal Register Notice: FDA releases a draft guidance, Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for T...

Panel to Discuss Boehringer NDA to Prevent Stroke

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 9/20 to discuss Boehringer Ingelheims ND...

FDA Plans Public Hearing on Standardized Patient Medication Info

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Federal Register Notice: FDA plans a public hearing 9/27-28 to discuss a single standardized document for patient medication infor...

Groups Want Animal Antibiotic Use Curtailed

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A coalition of consumer groups delivers 180,000 citizen letters to FDA asking for greater controls on use of animal antibiotics on...