Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced recently that it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal …
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WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, announced that it has completed enrollment in its Phase …
Read MoreWEST CHESTER, PA — Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced the approval of an Investigational New Drug (IND) …
Read MoreWASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized the marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy …
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WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, announced that its resubmitted New Drug Application (NDA) for …
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