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
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
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
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…
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. …
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…
Drug Name: Qalsody Indications: To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation. Active Ingredient: Tofersen Company: Biogen MA Inc. Approval Date: 4/25/2023 More Details: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215887s000lbl.pdf
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…
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…
Tradename: HYQVIA Proper Name: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase Indication: To extend the indication of Primary Immunodeficiency Diseases to pediatric patients from 2 years of age…