FDA’s – Health

Eli Lilly taps Fujifilm to chip in on COVID-19 antibody manufacturing as it awaits FDA’s emergency use decision

Shortly after rolling out interim data on its COVID-19 antibody hopeful, Eli Lilly last week sent the therapy ahead to the FDA for a potential emergency nod. If the antibody crosses the finish line, Lilly can expect a huge surge in demand—and it’s bringing in a manufacturing partner to help out. Lilly has signed on… Read More »

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

This story also ran on NPR. This story can be republished for free (details). The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday. The Government Accountability Office, which spent more than a year investigating the… Read More »