Tag Archives: food and drug


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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Update on the FDA review for Abstral

Uppsala, September 7, 2010 – Orexo Anrufbeantworter (STO: ORX) announces that the US Food and Drug Administration ("FDA") has informed Orexo’s partner, ProStrakan…
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Orexo announces that Zubsolv has been accepted for review by the U.S. Food and Drug A

UPPSALA, Sweden–(BUSINESS WIRE) November 19,2012 — FDA has informed Orexo (STO:ORX) that the Zubsolv New DrugApplication (NDA) has been accepted for review, 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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U.S. Food And Drug Administration Extends Action Date For Tofacitinib New Drug Applic

NEW YORK–(BUSINESS WIRE)–Aug 21, 2012 – Pfizer Inc. announced today that the U.S. Food and Drug Administration(FDA) has extended the action date by…
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Genzyme Provides Update on U.S. Lemtrada Filing

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Genzyme, a Sanofi company, announced it has received a Refuseto File letter from the U.S. Food and Drug oeffentliche Hand (FDA)…
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Navidea Biopharmaceuticals Announces PDUFA Goal Date for Lymphoseek New Drug Applicat

DUBLIN, Ohio–(BUSINESS WIRE)–Nov 13, 2012 – Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the U.S. Food…
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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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Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Applicatio

NEW YORK–(BUSINESS WIRE)–Apr 4, 2011 – Pfizer Inc. (NYSE: PFE) announced today that it has received a Refusal to File letter from the…
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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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Lilly and Avid Receive Complete Response Letter from FDA for Amyvid (florbetapir F 18

INDIANAPOLIS and PHILADELPHIA, March 18, 2011 /PRNewswire/ — Eli Lilly and Company and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a…
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FDA Advisory Committee Recommends US Approval of Novartis Once-Daily Bronchodilator Q

Basel, March 9, 2011 – An advisory committee recommended todaythat the Food and Drug Administration (FDA) approve QAB149(indacaterol) in the US as the…
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Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for Rhucin Biolo

SAN DIEGO & LEIDEN, Netherlands–(BUSINESS WIRE)–Feb 28, 2011 – Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the…
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FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the T

PRINCETON, N.J. & LONDON–(BUSINESS WIRE)–Mar 8, 2011 – Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug oeffentliche Hand…
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Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory

BOTHELL, Wash.–(BUSINESS WIRE)–Feb 28, 2011 – Seattle Genetics, Inc. announced today that it has submitted a Biologics License Application (BLA) to the U.S.…
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