The application is based on results from the phase II KEYNOTE-057 trial, which found that pembrolizumab has encouraging activity in patients with high-risk, BCG-unresponsive CIS with or without papillary tumors. The FDA has accepted and granted priority review for a...
Idecabtagene vicleucel is a CAR T-cell therapy that recognizes and binds to B-cell maturation antigen (BCMA) on the surface of multiple myeloma cells, leading to CAR T-cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. ...
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PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics to treat mental illness, neurological and pain disorders. Phar...
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The FDA recently approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults.
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the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research. ...