Biosimilar Rituximab-Arrx Approved for Rheumatoid Arthritis
The approval is supported by data from a phase 3 study that compared the efficacy, safety, pharmacokinetics and immunogenicity of Riabni to rituximab reference products.
The approval is supported by data from a phase 3 study that compared the efficacy, safety, pharmacokinetics and immunogenicity of Riabni to rituximab reference products.
Cerament G is a resorbable, gentamicin-eluting ceramic bone void filler.
The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.
The Pfizer-BioNTech COVID-19 vaccine can be administered as a single booster dose to individuals 5 to 11 years of age at least 5 months after completion of the primary series.
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.
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
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.