GSK says trial data show its Arexvy protects through three complete RSV seasons.
FDA says six products manufactured at Baxters hurricane-damaged facility in North Carolina are now on the shortage list.
Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act hits its 11/27 impl...
Neuvivo files an NDA for NP001 (sodium chlorite infusion) for treating amyotrophic lateral sclerosis (also known as Lou Gehrigs disease).
An FDA Science Advisory Board subcommittee calls on the agency to create a centralized office to coordinate work on New Alternative Methods.
FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protect human subjects.
FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manufacturing facility i...
FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, Malaysia.
