World News – GB – Immunomedics’ Trodelvy Receives US FDA Orphan Drug Designation for Glioblastoma – Express Pharma

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Immunomedics announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Trodelvy (sacituzumab govitecan-hziy) orphan status for the treatment of adult patients and pediatric patients with glioblastoma

“This orphan drug designation is an important milestone for Immunomedics as we strive to expand the clinical utility of Trodelvy As reported at the recent ESMO meeting, Trodelvy has shown encouraging activity in a study at early stage brain cancers, including partial responses in small cohorts of patients with brain metastases from breast cancer and recurrent glioblastoma, ”said Dr. Loretta M Itri, Chief Medical Officer of Immunomedics

Orphan drug status is granted by the FDA to support the development of drugs and biologics for underserved patient populations, or rare disorders that affect fewer than 200,000 people in the United States. orphan allows the company to benefit from various development incentives, including tax credits for qualified clinical studies, waiver of new drug application fees, and a designated period of market exclusivity after approval

Express Pharma, first published as Express Pharma Pulse in 1994, is now India’s premier bi-monthly market for the pharmaceutical industry With the patronage of its readers, Express Pharma has become The No1 Business News Magazine for the pharmaceutical industry Editorial content includes: news, opinions, analysis and interviews, under four main segments: market (the pharmaceutical business), management (overview for the management of the pharmaceutical industry), research (expertise for drug development) and pharmaceutical life (HR issues with a pharmaceutical company) focus) In addition to this, we publish periodic promotions like the Quarterly Pharma Technology Review, Special Packaging and LABNEXT

Immunomedic, orphan drug, Food and Drug Administration, glioblastoma, Sacituzumab govitecan, NASDAQ: IMMU, Pediatrics, Brain tumor

World news – GB – Immunomedics’ Trodelvy obtains orphan drug US FDA designation for glioblastoma – Express Pharma


SOURCE: https://www.w24news.com

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