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…
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…
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:…
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…
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…
Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its…
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. …