Tag: FDA
U.S. FDA Approves Bispecific Lunsumio VELO™ by Roche
Roche has made an announcement that the US Food and Drug Administration (FDA) has provided approval for CD20xCD3 bispecific Lunsumio VELO™-mosunetuzumab as a subcutaneous...
Cytokinetics Secures First FDA Approval With Myqorzo Heart Drug
Cytokinetics has reached a defining milestone after the U.S. Food and Drug Administration approved its heart drug Myqorzo for adults with obstructive hypertrophic cardiomyopathy,...
FDA Approves Inebilizumab-cdon for gMG Treatment in Adults
The U.S. Food and Drug Administration (FDA) has approved inebilizumab-cdon (Uplizna; Amgen) for the treatment of adults with generalized myasthenia gravis who are anti-acetylcholine...
FDA Approval of Gonorrhea Medications Broadens Oral Options
The U.S. Food and Drug Administration has approved two new oral medicines for the treatment of uncomplicated urogenital gonorrhea, marking an important regulatory step...
FDA Takes Steps to Decrease Animal Testing of New Medicines
The FDA has gone on to publish new guidance, which is aimed at reducing or stopping toxicity studies of monoclonal antibody-based drugs in non-human primates -...
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