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IN.PACT™ AV Drug-Coated Balloon Is First and Only to Show Superior and Sustained Results Through Two Years Compared to PTA in Treating Arteriovenous Fistulae Lesions

Share this article Share this article IN.PACT AV Access Trial 24 Month Results Presented as a Podium First at Charing Cross Symposium DUBLIN and LONDON, April 20, 2021 /PRNewswire/ Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the safety and effectiveness results through 24 months for the IN.PACT AV Access clinical study. The data, which were presented virtually as a podium first at the 2021 Charing Cross Symposium, demonstrated that the IN.PACT™ AV drug-coated balloon (DCB) is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal angioplasty (PTA) in end-stage renal disease (ESRD) patients with de novo or non-stented restenotic native arteriovenous fistulae (AVF) in the upper extremity.

Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biolo

Search jobs 09-Apr-2021 Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer - FDA Action Date is October 10, 2021 - - BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 - BOTHELL, Wash. & COPENHAGEN, Denmark (BUSINESS WIRE) Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a t

Seagen Inc.: Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

(1) - FDA Action Date is October 10, 2021 - - BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 - Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prog

Physics for Food Presse – Pressemitteilung

GT Biopharma : Announces GTB-3550 TriKE(TM) Reduces Bone Marrow Blast Levels, Improves NK Cell Function and Proliferation, and No Toxicities Observed in AML and MDS Patie