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...
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,...
Considering estimations predict that AI in the global healthcare market will reach $194.4 billion by 2030, it is clear that AI (artificial intelligence) is an increasingly crucial tool for the future of healthcare. CSOFT has written extensively on AI in our AI...
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...
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...
While Eli Lilly has withdrawn its request for European Union (EU) approval of its COVID-19 antibody-based treatment as the EU pivots its focus on other suppliers, the US has agreed to buy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...
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...
The US FDA (Food and Drug Administration) has announced new labels for boxed warnings, to further warn and inform consumer decision-making when considering the risks around breast implants. Included in this announcement, the FDA will also be limiting the sale and...
Bioproject has received approval from the European Medicines Agency (EMA) for their Ozawade (pitolisant) to treat adult excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). The approval is based on two Phase III clinical studies to study...
Novavax, a biotechnology company committed to development and bringing to market next-generation vaccines for critical infectious diseases, announced that it has finalized its ongoing regulatory submission to the U.K. Medicines and Healthcare products Regulatory...
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