The Flucelvax flu vaccine is the first approved in the U.S. that is derived from cell-based technology instead of the traditional egg-based process. It will be made at Novartis’ Holly Springs, N.C. plant.
Novartis AG’s Flucelvax influenza vaccine may be more important as an emergency preparedness milestone than as the seasonal product that FDA approved it as.
The seasonal flu vaccine is the first approved in the U.S. that is manufactured using cell-culture technology rather than the...
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
