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    "fda" — Press Releases

    8,207 releases found

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    📋 Business 📣 PR News
    FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as Adjuvant Treatment in BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer and Grants Priority Review. KENILWORTH, N.J., NJ-MERCK
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    Aufsichtsbehörden genehmigen Impella 5.5 mit SmartAssist Herzpumpe in Japan und Hongkong - US-Aufsichtsbehörde FDA erteilt bedingte IDE-Zulassung für Impella BTR Herzpumpe für frühe First-in-Human Machbarkeitsstudie. DANVERS, Mass., MA-ABIOMED
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    LEO Pharma: FDA-Zulassung von Adbry™ (Tralokinumab) als erste und einzige spezifisch auf IL-13 abzielende Behandlung für Erwachsene mit moderater bis schwerer atopischer Dermatitis. BALLERUP, Dänemark, LEO-PHARMA
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    LEO Pharma annonce l'approbation d'Adbry™ (tralokinumab) par la FDA en tant que premier et unique traitement spécifiquement ciblé sur l'IL-13 pour les adultes touchés par la dermatite atopique modérée à sévère. BALLERUP, Danemark, LEO-PHARMA
    Publisher  ·  2022
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    📋 Business 📣 PR News
    Takeda erhält vollständiges Antwortschreiben von der US-amerikanischen FDA für TAK-721. OSAKA, Japan & CAMBRIDGE, Massachusetts (USA), MA-TAKEDA-PHARMACEUTICAL
    Publisher  ·  2022
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    📋 Business 📣 PR News
    Solace Announces Latest Advances in Event Horizon Initiative, including Expansion of EDA Summit Program
    Publisher  ·  2022
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    📋 Health 📣 PR News
    Applied Pharmaceutical Science Inc. Announces FDA Approval of Investigational New Drug Application for APS03118, a Next generation RET Original New Drug for Unlimited Cancers
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Health 📣 PR News
    Glenmark Specialty S.A. (Switzerland) receives NDA Approval by the United States Food and Drug Administration (FDA) for Ryaltris™ Nasal Spray for the Treatment of Symptoms of Seasonal Allergic Rhinitis in Adults and Pediatric Patients 12 Years of Age and Older
    Publisher  ·  2022
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    📋 Business 📣 PR News
    Chetu Announces Unprecedented 2021 Growth Amid Prolific Expansion of Domestic & International Offices and Block of Hours Service Offerings. SUNRISE, Fla., FL-CHETU
    Publisher  ·  2022
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    📋 Business 📣 PR News
    MiX Telematics Announces Date of Third Quarter Fiscal Year 2022 Conference Call and Webcast. BOCA RATON, Fla., FL-MIX-TELEMATICS
    Publisher  ·  2022
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    📋 Business 📣 PR News
    KnowBe4 Finds U.S. Phishing Emails Focus on Password Alerts and Policy Changes While EMEA Focuses on Everyday Tasks. TAMPA BAY, Fla., FL-KNOWBE4
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    Apteco & Syniverse Collaborate to Offer WhatsApp as a Channel for Marketing Automation. WARWICK, United Kingdom & TAMPA, Fla., FL-SYNIVERSE
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    Veristat Supported Marketing Applications for 12% of all FDA Novel Drug Approvals in 2021. SOUTHBOROUGH, Mass., MA-VERISTAT
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    Les instances réglementaires autorisent la pompe Impella 5.5 avec SmartAssist au Japon et à Hong Kong au moment où la FDA américaine octroie une dispense conditionnelle de dispositif expérimental à Impella BTR dans le cadre de la première étude de.... DANVERS, Massachusetts, MA-ABIOMED
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Health 📣 PR News
    CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Health 📣 PR News
    AbbVie Submits Applications for Upadacitinib (RINVOQ®) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Business 📣 PR News
    BIOLASE and EdgeEndo Announce FDA 510(k) Clearance of New EdgePRO Laser-Assisted Microfluidic Irrigation Device for Endodontists
    Publisher  ·  2022
    Read Release → 📋 Pickups
    📋 Health 📣 PR News
    REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy
    Publisher  ·  2022
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    📋 Business 📣 PR News
    Avcon Caravan Aircraft Sensor Platform FAA STC Approved
    Publisher  ·  2022
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    📋 Business 📣 PR News
    ProcessMAP Partners With Hg, a Global Software Investor, to Accelerate Its Strategy Towards Becoming a Global Software Leader in Worker Health and Safety Management. FT. LAUDERDALE, Fla. & NEW YORK, NY-HG
    Publisher  ·  2022
    Read Release → 📋 Pickups
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