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Court Dismisses 1, Partially Dismisses Another Infuse Case

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A California federal court dismisses a case against Medtronic because it was filed later than the statute of limitations and allow...

MannKind Re-files NDA for Afrezza

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MannKind resubmits an NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder, indicated for improving glycemic control in...

Ex-FDA Head McClellan Joins J&J Board

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Former FDA commissioner Mark McClellan joins Johnson & Johnsons board of directors.

FDA Approves Tevas Generic Tobi

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FDA approves a Teva Pharmaceutical Industries ANDA for a generic copy of Novartis Tobi (tobramycin) inhalation solution.

Antares Otrexup Approved for Self Injection

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FDA approves an Antares Pharma NDA for Otrexup (methotrexate) injection, a subcutaneous methotrexate formulation for once weekly s...

Nepron Recalls 10 Albuterol Lots

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Nephron Pharmaceuticals recalls 10 lots of albuterol sulfate inhalation solution, 0.083%, in a 25-count packaging configuration.

CA Governor Brown Vetoes Biosimilar Bill

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Gov. Jerry Brown (D-CA) vetoes a bill that would have allowed biosimilar product substitution for products once FDA has made a det...

Positive Data in NPS Pharma Short Bowel Syndrome Trial

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NPS Pharmaceutical reports new data from a Phase 3 study of the long-term use of Gattex for injection in adults with Short Bowel S...

FDA Probes Increasing Blood Clot Reports with Iclusig

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FDA says it is investigating increasing reports of serious and life-threatening blood clots and severe narrowing of blood vessels ...

FDA Approves New Dosing for Medicures Aggrastat

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FDA approves a Medicure sNDA for a new dosing regimen for Aggrastat (tirofiban HCl).