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Tafamidis, sold under the brand names Vyndaqel and Vyndamax, [5] is a medication used to delay disease progression in adults with certain forms of transthyretin amyloidosis. It can be used to treat both hereditary forms, familial amyloid cardiomyopathy and familial amyloid polyneuropathy , as well as wild-type transthyretin amyloidosis , which ...
In May 2019, the FDA approved two tafamidis preparations for the treatment of transthyretin-mediated cardiomyopathy, but has not approved it for the treatment of transthyretin familial amyloid polyneuropathy. [15] In August 2018, the FDA approved patisiran, an siRNA-based treatment, at an expected cost of up to $450,000 per year. [16]
After a split vote by a Food and Drug Administration advisory panel, the agency will have the final say on whether Pfizer's (NYS: PFE) tafamidis meglumine is approved in the U.S. The decision won ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
(Reuters) -Alnylam Pharmaceuticals said on Monday it would not pursue expanded use of its drug to treat a potentially fatal heart disease in the U.S. after the Food and Drug Administration ...
Amyloidosis, hemophilia, and endocrine diseases under the Vyndaqel/Vyndamax, BeneFIX, and Genotropin brands. Pfizer anticipates full-year 2025 revenues in the range of $61.0 to $64.0 billion. This ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
The US Food and Drug Administration signed off Thursday on the first new type of pain reliever to be approved in more than two decades. The drug, suzetrigine, is a 50-milligram prescription pill ...