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...
Eli Lilly Retracts From EU, While US Buys Antibody Doses
While Eli Lilly has withdrawn its request for European Union (EU) approval of its COVID-19 antibody-based treatment as the EU pivots its focus on other suppliers, the US has agreed to buy 614,000 additional doses of Lilly's antibody combo for $1.29 billion. The...
Positive Data for Aquestive Therapeutics Sublingual Film
Aquestive Therapeutics, (previously MonoSolRX), known for specializing in the development and commercialization of products that meet unmet needs for patients, has announced positive topline data from its first-in-human Phase 1 PK study of AQST-109 sublingual film for...
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