Following the premiere of Bioethics International’s new diversity index in 2023, how can clinical trial translations improve a company’s future rating? Diversity in clinical trials has been a hot topic in recent years, even prompting the U.S. Food and Drug...
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. As I wrote in my introduction to this blog series, my aim here is to introduce and dissect one of the pertinent topics in the area...
Theseus Pharmaceuticals announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for THE-630 to treat patients with advanced gastrointestinal stromal tumors (GIST). GIST is the most common sarcoma of the gastrointestinal tract, and...
AbbVie has announced the U.S. Food and Drug Administration (FDA) approval for RINVOQ (upadacitinib) to treat refractory, moderate to severe atopic dermatitis in children 12 years and older and adults. Atopic dermatitis, more commonly known as eczema, is a chronic skin...
Cstone Pharmaceuticals has announced the U.S. Food and Drug Administration’s (FDA) STUDY MAY PROCEED (SMP) letter and investigational new drug (IND) application approval for CS5001, a potential antibody-drug conjugate (ADC) to target receptor tyrosine kinase-like...
VBI Vaccines’ drug candidate PreHevbrio, developed to prevent infection among patients diagnosed with the hepatitis B virus, has been approved by the U.S. Food and Drug Administration (FDA). Affecting around 296 million people worldwide, chronic hepa-B infection is a...
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