The randomized, double-blind, placebo-controlled MONeT trial evaluated the immunogenicity and safety of Abrysvo in adults 18 years and older at risk of RSV-associated disease.
Drugs in the Pipeline
Elamipretide is a peptide compound designed to penetrate cell membranes targeting the inner mitochondrial membrane where it binds reversibly to cardiolipin.
The drug/device combination therapy provides a continuous subcutaneous infusion of apomorphine through an infusion pump.
The sBLA is supported by data from the phase 3 BE HEARD I and BE HEARD II studies.
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
Both trials met the primary and secondary near vision improvement endpoints.
DD01 is a long-acting dual agonist of glucagon-like peptide-1 and glucagon receptors.
Dato-DXd is a specifically engineered TROP2-directed DXd antibody drug conjugate.
The YELLOWSTONE clinical development program includes two 12-week double-blind, placebo-controlled induction studies.
The application is supported by data from the pivotal phase 3 IB1001-301 trial, which evaluated the efficacy and safety of IB1001 in patients 4 years of age and older with NPC.
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