The FDA has rejected the submission of Gilead for approval of filgotinib in rheumatoid arthritis. With the FDA requesting to see data from an ongoing clinical trial, Gilead is unlikely to be able to refill until after the middle of next year, pushing it even further behind its rivals for …
Read More »
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Friday that the chances of a coronavirus vaccine with 98% or more guaranteed protection are “not great,” according to CNBC. Yes, but: The Food and Drug Administration says it is ready to authorize a vaccine for coronavirus …
Read More »
Last week, FDA staff raised concerns about eye-related side effects that may come with GlaxoSmithKline’s BCMA cancer treatment. Despite questions about whether those problems, which include loss of vision, so severe patients stopped reading or driving, could be effectively identified and managed, the drug came out of an advisory committee …
Read More »