Tag Archives: drug application

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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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U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tube

RARITAN, N.J., Sept. 5, 2012 /PRNewswire/ — Janssen Research& Development, LLC (Janssen) announced today that the U.S. Foodand Drug oeffentliche Hand (FDA) has…
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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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Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Mar 9, 2011 – Merck, known as MSD outside the United States and Canada,announced today that the New Drug Application…
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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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Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Appli

DARMSTADT, Germany, March 2, 2011 ? Merck Kommanditgesellschaft auf Aktien announced today that it received a complete response letter from the FDA on…
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FDA Accepts Lundbeck Inc. Submission of New Drug Application for Clobazam

DEERFIELD, Ill.–(BUSINESS WIRE)–Mar 4, 2011 – Lundbeck Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review a New…
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FDA Denies Taliglucerase Alfa New Drug Application

February 25, 2011 – On Friday morning, Protalix BioTherapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has issued a Complete…
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FDA Issues Complete Response to New Drug Application for Contrave for the Management

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US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)

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Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011

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Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of

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AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor T

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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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