FDA Flags Potential Guillain-Barre Risk With RSV Vaccine Candidates
Ahead of a 2-day meeting with FDA’s vaccine advisors, reviewers at the agency highlighted a rare but potential risk for Guillain-Barré syndrome with two vaccine candidates for respiratory syncytial virus (RSV). On Tuesday and Wednesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will recommend whether the risk-benefit profile with Pfizer and GSK’s vaccine […]
PI3K Inhibitor Fails to Pass Muster With FDA Advisory Committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made a clean sweep of its 2-day meeting, deciding that the PI3K inhibitor duvelisib (Copiktra) does not offer a favorable risk-benefit ratio for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). By an 8-4 vote, the panel came down on the side of the FDA […]