Elecsys HIV Duo to screen blood donors
Tradename: Elecsys HIV Duo Proper Name: Elecsys HIV Duo Indication: Intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is…
MenQuadfi for active prevention of invasive meningococcal disease
Tradename: MenQuadfi Proper Name: Meningococcal (Groups A, C, Y, W) Conjugate Vaccine Indication: To include safety and effectiveness data from clinical studies MET59 and MEQ66 in support of booster vaccination…
VAXNEUVANCE for prevention of invasive disease by Streptococcus pneumoniae
Tradename: VAXNEUVANCE Proper Name: Pneumococcal 15-valent Conjugate Vaccine Indication: To include results from study V114-022 in the “Use in Specific Populations” section of the package insert, for pediatric and adult…
SHINGRIX for prevention of herpes zoster (shingles)
Tradename: SHINGRIX Proper Name: Zoster Vaccine Recombinant, Adjuvanted Indication: To include data on safety and the immune responses to SHINGRIX when administered concomitantly with Pneumococcal Vaccine Polyvalent (Pneumovax 23), Pneumococcal…
VYJUVEK for wound treatment in patients with dystrophic epidermolysis bullosa
Tradename: VYJUVEK Proper Name: beremagene geperpavec-svdt Indication: Indicated for treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type…
AREXVY to prevent respiratory tract disease by respiratory syncytial virus
Tradename: AREXVY Proper Name: Respiratory Syncytial Virus Vaccine, Adjuvanted Indication: Indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60…
GARDASIL 9
Tradename: GARDASIL 9 Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant Indication: To include clinical data from the long-term follow-up study V503-002-20 in support of modifications to the package insert. …
WOWST to prevent recurrence of Clostridioides difficile infection
Tradename: VOWST Proper Name: fecal microbiota spores, live-brpk Indication: To prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for…
OMISIRGE for use in cord blood transplantation patients with hematologic malignancies
Tradename: OMISIRGE Proper Name: omidubicel-onlv Indication: Indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following…
COAGADEX for perioperative management of bleeding including Factor X deficiency patients
Tradename: COAGADEX Proper Name: Coagulation Factor X, (human) Indication: To expand the indication for perioperative management of bleeding to include patients with severe hereditary Factor X deficiency based on submission…