The dog days of summer may have come to early to the US FDA, which last approved a novel agent more than a month ago.
COVID-19 is, again, a cause of delays. BeiGene, Ltd./Novartis AG’s immuno-oncologic tislelizumab became the latest casualty of the FDA’s inability to conduct inspections in China, joining what had been the shrinking ranks of applications with missed user fee goal dates while the FDA waits on facility access. Coherus BioSciences, Inc