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Medimmune Receives Complete Response Letter On Motavizumab

AstraZeneca today announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the U.S. Food and…
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Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointesti

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 30, 2012/PRNewswire/ — Bayer HealthCare and Onyx Pharmaceuticals today announced that Bayer HealthCare has submitted…
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Noven Submits New Drug Application for Investigational Non-Hormonal Therapy for Menop

MIAMI & NEW YORK–(BUSINESS WIRE)–Aug 29, 2012 – NovenPharmaceuticals, Inc., a wholly-owned subsidiary of HisamitsuPharmaceutical Co., Inc., today announced that it has submitted…
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Halozyme Confirms Baxter Has Received A Complete Response Letter For HyQ BLA

SAN DIEGO, Aug. 1, 2012 /PRNewswire/ — Halozyme Therapeutics, Inc. today announced that the Center for BiologicsEvaluation and Research (CBER) of the U.S.…
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FDA Accepts Noven’s NDA For An Investigational Nonhormonal Therapy For Menopausal Vas

IAMI, FL and NEW YORK, NY, Nov. 12, 2012 /PRNewswire/ — NovenPharmaceuticals, Inc., a wholly-owned subsidiary of HisamitsuPharmaceutical Co., Inc., today announced that…
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New Drug Applications Submitted in the United States and Europe for Vemurafenib in Ad

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–May 11, 2011 – Genentech, a member of the Roche Group today announced that the company submitted a New…
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FDA Assigns PDUFA Date for Shire’s Firazyr (icatibant) for the Treatment of Acute Att

DUBLIN and LEXINGTON, Massachusetts, March 21, 2011/PRNewswire-FirstCall/ — Shire plc, the irdisch specialty biopharmaceutical company, today announced that the US Food and Drug…
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Shire Files Complete Response to FDA’s Not Approvable Letter for Firazyr (icatibant)

DUBLIN, Ireland and LEXINGTON, Massachusetts, February 28, 2011/PRNewswire-FirstCall/ — Shire plc, the irdisch specialty biopharmaceutical company, today announced that it has submitted a…
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Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of

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VIVUS Provides Regulatory Update on Qnexa NDA

MOUNTAIN VIEW, Calif., Jan. 21, 2011 /PRNewswire/ — VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug…
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MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza

VALENCIA, Calif.–(BUSINESS WIRE)–Jan 19, 2011 – MannKind Corporation today announced that it has received a complete response letter from the U.S. Food &…
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Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment

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FDA Accepts Exelbine NDA for Filing

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MannKind Updates Status of New Drug Application for Afrezza

VALENCIA, Calif.–Dec. 28, 2010–BUSINESS WIRE–MannKind Corporation today announced that it was informed on December 27, 2010 by the U.S. Food & Drug Administration…
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Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Applica

SAN DIEGO, Dec. 20, 2010 ? Amylin Pharmaceuticals, Inc. today announced that it has submitted the initial sections of a rolling submission for…
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