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...
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.
CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.
The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.
