The new packaging allows for ease of administration and convenience.
Buerger disease typically affects young or middle aged male cigarette smokers.
Efruxifermin is a differentiated Fc-FGF21 fusion protein designed to mimic the biological activity of fibroblast growth factor 21.
N-nitroso-irbesartan is a probable human carcinogen based on results from laboratory tests.
The submission is based on data from the phase 3 MOVe-OUT trial, which evaluated molnupiravir in 775 nonhospitalized adults with mild to moderate COVID-19.
Starting aspirin in patients 60 years or older to prevent a first heart attack or stroke is not recommended.
The approval was based on data from the phase 3 ADVOCATE trial, which evaluated Tavneos in 330 adults with newly diagnosed or relapsed ANCA-associated vasculitis.
The removal of the contraindication to screen for hypersensitivity to blood and blood products is expected to improve workflow efficiency for health care professionals.
The submission is supported by data from the phase 3 PROVENT and STORM CHASER trials.
The planned interim analysis included data from 775 adult patients with mild to moderate COVID-19.
