Expanded indication
WebMay 3, 2024 · CLINICAL STUDY — FDA approval of the expanded indication for Entresto was based on the results of a double-blind trial (PARAGON-HF) in 4822 patients with NYHA class II-IV heart failure, LVEF ≥45%, elevated levels of natriuretic peptides, and structural heart disease. The primary endpoint was a composite of total hospitalizations for heart ... WebFeb 21, 2024 · With the expanded indication, an additional 1.2 million U.S. patients 1 are now eligible to benefit from advanced monitoring with the CardioMEMS sensor, which marks a significant increase over the current addressable population. The sensor provides an …
Expanded indication
Did you know?
WebExtension Indication has the meaning assigned to such term in Section 1.37. Extension Indication means the [***]. Extension Indication means the diagnosis, prevention and … WebOct 14, 2015 · Central nervous system malignancies. On 5 October, 2015 the US Food and Drug Administration (FDA) approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include surgery, …
WebMar 16, 2024 · This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. … WebMar 17, 2024 · Recently the FDA announced approval for an expanded indication for reducing the risk of cardiovascular death and hospitalization for heart failure (HF) in adult …
WebJul 13, 2024 · The expanded indication based on the PROSPER data builds on the body of evidence for XTANDI.” Pfizer and Astellas are committed to helping patients access … WebJul 6, 2024 · “This expanded indication reinforces the role of KEYTRUDA in this cancer type, which is the second most common form of non-melanoma skin cancer.” Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated …
WebFeb 3, 2024 · “Today’s approval of the expanded indication of TAKHZYRO represents a significant step forward for the HAE community as it helps some of its youngest patients who are living with the disease to have a long-term prophylaxis treatment available to them,” said Julie Kim, president, U.S. Business Unit and U.S. country head at Takeda. ...
WebMar 14, 2024 · ABBOTT PARK, Ill., March 14, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for a new, expanded indication to its leading MitraClip ™ device used to repair a leaky mitral valve without open-heart surgery. Supported by the results of the landmark COAPT™ … petch butchersWebApr 11, 2024 · Horizon Therapeutics (HZNP) announces positive top-line data from its phase IV study of Tepezza to expand its indication to include TED in adult patients with chronic/low clinical activity scores. petch chiropracticWebJan 25, 2024 · Cambridge, MA, January 25, 2024.The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo ® (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions. The efficacy supplemental Biologics … petchchyy