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Panel to Discuss Serotonin Receptor 4 Agonists

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/17 to provide recommendations to FDA on prema...

FDA Report on Treating Allergic Disease

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Federal Register Notice: FDA releases a report of scientific and medical literature and information on the use of non-standardized...

CDER Adds 2 Offices Under Office of Medical Policy

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Federal Register Notice: FDA reorganizes CDER by establishing two offices under the Office of Medical Policy: Office of Prescripti...

Amarin Submits NDA for Triglyceride Therapy

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Amarin files an NDA for AMR101 for treating patients with very high triglycerides.

FDA Clears Smiths Medical Medfusion Infusion Pump

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FDA clears a Smiths Medical 510(k) for its new Medfusion 4000 wireless syringe infusion pump with the PharmGuard infusion manageme...

FDA Explores 'Mechanism' for Reporting Drug Shortages

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FDA examines developing a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which c...

FDA 'Orphan' Status for Hodgkin's Drug

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FDA grants 4SC AG an orphan drug designation for its lead oncology compound resminostat in Hodgkin's lymphoma.

AIDS Group Sues FDA on FOI Denials

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AIDS Healthcare Foundation sues FDA over the denial of the group's Freedom of Information Act (FOIA) requests seeking information ...

FDA OKs Medistem Stem Cell Trial for Critical Limb Ischemia

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FDA approves initiation of a Medistem Inc. clinical trial of its Endometrial Regenerative Cell adult stem cell product in patients...

ImmunoGen IND for B-cell Malignancies

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ImmunoGen files an IND for IMGN529, a potential new treatment for B-cell malignancies including non-Hodgkin's lymphoma and chronic...