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The US FDA approved rituximab-abbs (Truxima) in 2018, [1] [75] [76] rituximab-pvvr (Ruxience) in 2019, [2] and rituximab-arrx (Riabni) in 2020. [3] [85] [86] Truxima and Riabni are approximately $3600 per 500 mg, wholesale - 10% less than Rituxan, while Ruxience is 24% less than Rituxan. [87] [88] The Indian biosimilar ituxredi retails for ...
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]
In April 2023, upadacitinib was approved in the EU for the treatment of moderately to severely active Crohn's disease in adults. [21] [22] [23] In May 2023, the FDA approved upadacitinib for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.
Ionis Pharmaceuticals, Inc. is a biotechnology company based in Carlsbad, California, that specializes in discovering and developing RNA-targeted therapeutics.The company has three commercially approved medicines: Spinraza (), Tegsedi (), and Waylivra (Volanesorsen), and has four drugs in pivotal studies: tominersen for Huntington's disease (together with Roche), tofersen for SOD1-ALS, AKCEA ...
In January 2023, the US Food and Drug Administration (FDA) granted accelerated approval to tucatinib in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. [12]
On Sept. 20, the Food and Drug Administration approved the first-ever vaccine that adults can give themselves or caregivers can administer to others. The same nasal spray, FluMist, has been ...
Novo's weight loss drug Wegovy won approval from China, the world's second-largest economy and the country estimated to hold the highest number of overweight or obese people, in June in a move ...
(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's inhaled drug for types of lung disorders, and allowed only tentative clearances, sending ...