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Agency Accepts Actelion NDA for Pulmonary Arterial Hypertension

[ Price : $8.95]

FDA accepts an Actelion NDA for Opsumit (macitentan), indicated for treating patients with pulmonary arterial hypertension.

Bayer Files NDA for Prostate Cancer

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Bayer HealthCare submits an NDA for radium Ra 223 dichloride, an investigational compound for treating castration-resistant prosta...

FDA Rejects Jazz Pharma Petition on Xyrem REMS

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FDA denies a Jazz Pharmaceutical citizen petition that asked the agency to not accept any ANDA referencing its Xyrem that did not ...

Long-awaited Enrichment Studies Guidance Released

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FDA posts a long-awaited draft guidance on clinical trial enrichment strategies that can be used in studies to support effectivene...

FDA Clears Insulet OmniPod Insulin System

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FDA clears an Insulet Corp. 510(k) for the OmniPod Insulin Management System.

Panel to Discuss GSK Breo Ellipta for COPD

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 3/7/13 to discuss a GlaxoSmithKline NDA for the...

Researchers ID Potential Drug Combos for Melanoma

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Yale University of Medicine researchers develop a new screening approach to evaluate cancer drugs in combination with other drugs ...

Appeals Court Finds Crestor Patent Valid

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The Federal Circuit Court of Appeals rules that a substance patent protecting AstraZenecas Crestor is valid and enforceable.

Novartis Orphan Drug Signifor OKd for Cushing's Disease

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FDA approved Novartis Pharma Stein AGs Signifor for Cushings disease patients who cant be helped through surgery.

Lilly Plans Additional Alzheimers Drug Study

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Lilly says it will conduct an additional Phase 3 study of its investigational Alzheimers drug solanezumab before submitting a BLA ...