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Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. [18] It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia (in children and adults, but not recommended in elderly patients), rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura ...
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of conditions. These medications are “slated to make a big clinical impact."
The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin, originally approved as a biologic under the FD&C Act. [14] On March 6, 2015, Zarxio obtained the first approval of FDA. [15]
The treatment, Tivdak - an antibody-drug conjugate co-developed by Genmab A/S and Seagen - received the FDA's accelerated approval for the same indication in 2021. It was added to Pfizer's ...
2024 saw a new drug enter the dementia landscape, as the U.S. Food and Drug Administration (FDA) approved Kisunla (donanemab) in July. This was the third new approval since 2021.
In August 2019, it was approved by U.S. FDA for treatment of giant-cell tumor of the tendon sheath (GC-TS). [2] [6] [7] Pexidartinib is available in the US only through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program. [2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]
The Food and Drug Administration on Friday approved Pfizer’s treatment for a rare genetic bleeding disorder, making it the company’s first-ever gene therapy to win clearance in the U.S.
The U.S. Food and Drug Administration (FDA) granted the application for pafolacianine orphan drug, priority review, and fast track designations. [ 2 ] [ 4 ] [ 11 ] [ 8 ] The FDA granted the approval of Cytalux to On Target Laboratories, LLC.