Tradename: ELEVIDYS Proper Name: delandistrogene moxeparvovec-rokl Indication: Indicated for treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the…
Drug Name: Columvi Indications: To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy. Active…
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…
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…
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
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…
Drug Name: Posluma Indications: To use with positron emission tomography imaging in certain patients with prostate cancer. Active Ingredient: Flotufolastat F 18 Company: Blue Earth Diagnostics Ltd. Approval Date: 5/25/2023…
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…
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…