The new packaging allows for ease of administration and convenience.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
The expanded approval was based on data from a phase 3 study that compared Flucelvax Quadrivalent to a US-licensed comparator quadrivalent influenza vaccine.
The approval was based on data from the phase 3 heiGHt trial, which compared Skytrofa to somatropin in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
Rethymic is engineered human allogeneic thymus tissue designed to reconstitute the immune system in pediatric patients with congenital athymia.
The BLA submission is supported by data from two phase 3 trials that included more than 6000 patients.
Starting aspirin in patients 60 years or older to prevent a first heart attack or stroke is not recommended.
Adlarity is a once-weekly transdermal formulation of donepezil.
The modified iPLEDGE REMS will go into effect starting December 13, 2021.