In 2021, FDA approved more than 60 oncology drugs and biologics including dangling accelerated Approvals, drug dosing, new approvals and more. This recently published article coauthored by FDA’s Steven Lemery and Richard Pazdur provides a nice summary of FDA...
Influenza vaccines typically coax the immune system to generate antibodies that recognize the head of hemagglutinin (HA), a protein that extends outward from the surface of the flu virus. The head is the most accessible regions of HA, making it a good target for the...
We read a really interesting article on the current state of COVIS-19 antibody testing that is also a very lucid introduction to the principles behind ELISAs and lateral flow immunoassays. The article titled “Why the Accuracy of SARS-CoV-2 Antibody Tests Varies So...
FDA has issued guidelines for the conduct of clinical trials during the COVID-19 pandemic. “With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical...
To provide some diversion during these trying times, a colleague recommended ‘The infinite Monkey Cage’. Extremely funny British science podcast. There are more than 10 seasons for your pleasure. You will learn and you will laugh. If you like Monty Python you are on...