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Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”
This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.
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Outbreaks declared over, investigation advances, root cause analysis continues
Submission Based on Positive Pivotal HER2CLIMB Trial Results Recently Presented at the 2019 San Antonio Breast Cancer Symposium and Published in the New England Journal of Medicine
1st Marketing Application Submission in U.S. for Gene Therapy Directed at Any Type of Hemophilia
Assigns PDUFA Goal Date of May 25, 2020
Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug.
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The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope.
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In Phase 2b development for the treatment of life-threatening fungal infections
Dental labs and clinics can produce dentures 75% faster with 90% lower cost using 3D Systems' Digital Denture Workflow
Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)
Fulfilling its pledge to remove millions of opioid pills from the medicine cabinets of American homes, DisposeRx recently donated over 150,000 packets of its non-toxic, safe solution for the disposal of unused or expired medications to 140 community partners in 43 states through its community outreach program.
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.
Progress Toward the Goal of Achieving a Functional Cure for HIV Disease
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Hackensack Meridian Health has invested $1 million in a comprehensive strategy to curb the vaping epidemic through its "Take Vape Away" campaign.
The designation was supported by results from the Phase III INBUILD® study that met its primary endpoint and was recently published in the New England Journal of Medicine