The BLA is supported by data from a clinical trial which included 2341 healthy individuals 10 through 25 years of age.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
The issue appears to be related to the availability of generic oseltamivir.
The bivalent vaccine contains the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The BLA is supported by data from the phase 3 RENOIR trial which included approximately 37,000 adults 60 years of age and older.
The all-oral and combination treatment arms demonstrated statistically significant composite responses of 10.1% and 19.2%, respectively.
The bivalent vaccine contains the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The BLA is supported by data from the pivotal TIDES trial which included over 20,000 patients 4 to 16 years of age.
Kineret is an interleukin-1 receptor antagonist.
The approval was supported by data from a phase 2 trial that included 70 patients aged 12 to less than 18 years with chronic HBV infection.
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors.
The Menveo 1-vial presentation does not require reconstitution before use and is expected to be broadly available in mid-2023.
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
Topline results were announced from a phase 3 trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women.
The approval was based on data from the phase 3 TMB-302 trial that evaluated Trogarzo 800mg administered via IV push once every 2 weeks.
The administration of recalled product may lead to inflammation, allergic reactions, or circulatory system complications.
The clinical development program for RBX2660 included 6 studies with a total of 1061 patients, of which 978 were treated with RBX2660.
The randomized, active-controlled, observer-blinded trial included 2341 healthy individuals 10 through 25 years of age.
A 50mcg booster dose of mRNA-1273.214 elicited significantly higher neutralizing antibody responses against Omicron subvariants BA.4 and BA.5 in adults.
In the CRL, the FDA stated that the application could not be approved in its present form and that an additional clinical trial would be required.
Positive topline results were announced from two phase 3 studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine, in pediatric patients for the prevention of invasive pneumococcal disease.
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
