Wednesday, May 31, 2023

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FDA approved Pivotal Phase III Trial Design of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)

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The U.S. Food and Drug Administration (FDA) approved Medical devices (pacemakers and defibrillators)That Help Keep the Heart Beating

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Merck’s Ebola Vaccine (Ervebo) Approved in Europe by the European Commission

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Aquestive Therapeutic’s Libervan (diazepam) Buccal Film Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for the Management...

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FDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3 inhibitor) in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with...

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The European Commission approved Celltrion’s Remsima SC (infliximab) trials for the treatment of Chron’s disease, ulcerative colitis and rheumatoid arthritis

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EOS imaging receives U.S. FDA 510(k) clearance for EoSedge™ its new generation innovative imaging system , EoSedge in Europe, Canada and Australia

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Y-mAbs Initiates Submission of Biologics License Application to U.S. FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma

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US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the...

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Collaboration of Bayer and Pharmaron to develop new molecular entities for veterinary medicines

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QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Plus Test the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s...

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NICE approves Ibrance via Cancer Drugs Fund in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+) and HER2-...

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