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…
Inpefa to treat heart failure
Drug Name: Inpefa Indications: To treat heart failure. Active Ingredient: Sotagliflozin Company: Lexicon Pharmaceuticals, Inc Approval Date: 5/26/2023 More Details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216203s000lbl.pdf
Paxlovid to treat mild-to-moderate COVID-19
Drug Name: Paxlovid Indications: To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19. Active Ingredient: Nirmatrelvir, Ritonavir Company: Pfizer Labs Approval Date: 5/25/2023 More…
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…
Xacduro to treat hospital-acquired pneumonia
Drug Name: Xacduro Indications: To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Active Ingredient: Sulbactam, Durlobactam Company: Entasis Therapeutics Ltd Approval…
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…
Epkinly to treat large B-cell lymphoma
Drug Name: Epkinly Indications: To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy. Active Ingredient:…
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…