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"fda" โ Press Releases
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FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZAยฎ (olaparib) as Adjuvant Treatment in BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer and Grants Priority Review. KENILWORTH, N.J., NJ-MERCK
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Aufsichtsbehรถrden genehmigen Impella 5.5 mit SmartAssist Herzpumpe in Japan und Hongkong - US-Aufsichtsbehรถrde FDA erteilt bedingte IDE-Zulassung fรผr Impella BTR Herzpumpe fรผr frรผhe First-in-Human Machbarkeitsstudie. DANVERS, Mass., MA-ABIOMED
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LEO Pharma: FDA-Zulassung von Adbryโข (Tralokinumab) als erste und einzige spezifisch auf IL-13 abzielende Behandlung fรผr Erwachsene mit moderater bis schwerer atopischer Dermatitis. BALLERUP, Dรคnemark, LEO-PHARMA
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LEO Pharma annonce l'approbation d'Adbryโข (tralokinumab) par la FDA en tant que premier et unique traitement spรฉcifiquement ciblรฉ sur l'IL-13 pour les adultes touchรฉs par la dermatite atopique modรฉrรฉe ร sรฉvรจre. BALLERUP, Danemark, LEO-PHARMA
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Takeda erhรคlt vollstรคndiges Antwortschreiben von der US-amerikanischen FDA fรผr TAK-721. OSAKA, Japan & CAMBRIDGE, Massachusetts (USA), MA-TAKEDA-PHARMACEUTICAL
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Solace Announces Latest Advances in Event Horizon Initiative, including Expansion of EDA Summit Program
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Applied Pharmaceutical Science Inc. Announces FDA Approval of Investigational New Drug Application for APS03118, a Next generation RET Original New Drug for Unlimited Cancers
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Glenmark Specialty S.A. (Switzerland) receives NDA Approval by the United States Food and Drug Administration (FDA) for Ryaltrisโข Nasal Spray for the Treatment of Symptoms of Seasonal Allergic Rhinitis in Adults and Pediatric Patients 12 Years of Age and Older
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Chetu Announces Unprecedented 2021 Growth Amid Prolific Expansion of Domestic & International Offices and Block of Hours Service Offerings. SUNRISE, Fla., FL-CHETU
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MiX Telematics Announces Date of Third Quarter Fiscal Year 2022 Conference Call and Webcast. BOCA RATON, Fla., FL-MIX-TELEMATICS
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KnowBe4 Finds U.S. Phishing Emails Focus on Password Alerts and Policy Changes While EMEA Focuses on Everyday Tasks. TAMPA BAY, Fla., FL-KNOWBE4
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Apteco & Syniverse Collaborate to Offer WhatsApp as a Channel for Marketing Automation. WARWICK, United Kingdom & TAMPA, Fla., FL-SYNIVERSE
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Veristat Supported Marketing Applications for 12% of all FDA Novel Drug Approvals in 2021. SOUTHBOROUGH, Mass., MA-VERISTAT
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Les instances rรฉglementaires autorisent la pompe Impella 5.5 avec SmartAssist au Japon et ร Hong Kong au moment oรน la FDA amรฉricaine octroie une dispense conditionnelle de dispositif expรฉrimental ร Impella BTR dans le cadre de la premiรจre รฉtude de.... DANVERS, Massachusetts, MA-ABIOMED
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CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA
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AbbVie Submits Applications for Upadacitinib (RINVOQยฎ) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)
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BIOLASE and EdgeEndo Announce FDA 510(k) Clearance of New EdgePRO Laser-Assisted Microfluidic Irrigation Device for Endodontists
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REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy
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Avcon Caravan Aircraft Sensor Platform FAA STC Approved
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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
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