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…
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…
Posluma for prostate cancer imaging
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…
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…
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…
Miebo to treat dry eye disease
Drug Name: Miebo Indications: To treat signs and symptoms of dry eye disease. Active Ingredient: Perfluorhexyloctane Company: Bausch & Lomb Incorporated Approval Date: 5/18/2023 More Details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216675s000lbl.pdf
Veozah to treat menopause hot flashes
Drug Name: Veozah Indications: To treat moderate to severe hot flashes caused by menopause. Active Ingredient: Fezolinetant Company: Astellas Pharma US, Inc. Approval Date: 5/12/2023 More Details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216578s000lbl.pdf
Elfabrio to treat Fabry disease
Drug Name: Elfabrio Indications: To treat confirmed Fabry disease. Active Ingredient: Pegunigalsidase alfa-iwxj Company: Chiesi USA, Inc. Approval Date: 5/9/2023 More Details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761161s000lbl.pdf