Immuno-Oncology’s ‘Infancy’? ‘Adolescence?’ Wherever You Peg Development, Adverse Event Reporting Needs To Mature
A common toxicity of advanced IO therapies, cytokine release syndrome needs to be better characterized as part of the groundwork for future development of the field, according to Friends of Cancer Research.
You may also be interested in...
Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.
Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.