MEI Pharma and Kyowa Kirin’s Zandelisib Given ODD Status
The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to Zandelisib, a drug produced in collaboration between MEI Pharma and Kyowa Kirin Inc for the treatment of follicular lymphoma (FL). Developed as a once-daily, oral investigational...
Plus Therapeutic’s Rhenium-186 Gains Fast Track Designation
The U.S. Food and Drug Administration (FDA) has given Plus Therapeutics Inc. a Fast Track Designation for Rhenium-186 NanoLiposome (186 RNL), a novel drug for the treatment of leptomeningeal metastases (LM). As a rare complication of cancer, LM primarily occurs with...
Pops Self-Care Platform Gains Australian Clearance
The Therapeutic Goods Administration, Australia’s regulatory body, has given clearance to Pops, a digital health company dedicated to addressing chronic conditions including diabetes. Pops, which has already been commercialized in the United States, gained prominence...
FDA Grants ODD Status to SEL24/MEN1703 for Treatment of AML
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SEL24/MEN1703, an orally available, dual PIM/FLT3 inhibitor designed for the treatment of Acute Myeloid Leukemia (AML). Licensed by the Menarini group from Ryvu Therapeutics,...
HPV Vaccinations: UK Cervical Cancer Program Shows Success
The results of an England-based national program to vaccinate females against human papillomavirus (HPV) to protect against cervical cancer has shown significant success, new data from England shows. Among this success is a reported 87% decrease in cervical cancer...
FDA Grants Memgen IND Application Clearance
The US FDA (Food and Drug Administration) has granted IND (investigational new drug) application clearance for Memgen’s MEM-288, their cancer immunotherapy treatment for patients with multiple solid tumors. Following this announcement, Memgen, a clinical-stage...
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