FDA Declines EUA Request for Fluvoxamine for COVID-19 Treatment
The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.
The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.
The test is the first non-prescription multi-analyte COVID-19 test that allows individuals to test nasal swab samples self-collected at home.
The approval was supported by data from a phase 2/3 CARAVAN study.
The FDA urges consumers to buy prescription drugs, such as Adderall, from state-licensed US pharmacies or physicians located in the US.
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
These recommendations only apply to individuals who do not have a history of CVD and are not already taking daily aspirin.
The FDA has extended shelf-life for the Janssen COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine following a thorough review of data submitted by both manufacturers.
The guidance aims to ensure that the data submitted to the Agency adequately represent the patients that will use the medical products.
Dupilumab is an interleukin-4 receptor alpha antagonist.
The approval was based on two phase 3 trials which evaluated Ibsrela in over 1200 adults with IBS-C.