Reports of Injuries Prompt FDA Alert on Proper At-Home COVID-19 Test Use
The incorrect use of these tests may cause harm if, for instance, the liquid solution comes in contact with the skin, nose, mouth, or eyes, or if it is swallowed.
The incorrect use of these tests may cause harm if, for instance, the liquid solution comes in contact with the skin, nose, mouth, or eyes, or if it is swallowed.
SP-102 is a dexamethasone sodium phosphate viscous gel formulation that is administered by epidural injection.
This submission comes shortly after Pfizer and BioNTech submitted an EUA request for an additional booster dose of their COVID-19 vaccine for adults 65 years of age and older.
The phase 3 MAGNITUDE study assessed niraparib in combination with abiraterone acetate plus prednisone in patients with mCRPC with or without alterations in homologous recombination repair associated genes.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
The phase 3 CERTAIN-1 study compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI.
The PROGRESS study compared the efficacy and safety of atogepant to placebo in 778 adults with at least a 1-year history of chronic migraine.
The approval was based on data from the phase 3 EMPEROR-Preserved trial.
The EUA was supported by data from the phase 2 BLAZE-4 trial which evaluated bebtelovimab in nonhospitalized patients with mild to moderate COVID-19.
The 2022 adult immunization schedule summarizes ACIP recommendations, including several changes.