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Vutrisiran significantly improved multiple disease-relevant outcomes versus placebo, with an acceptable safety profile. [19] These findings from HELIOS-A resulted in FDA and EMA approval of vutrisiran for treatment of ATTRv-PN. [16]
Vutrisiran was approved by the U.S. Food and Drug Administration (FDA) in June 2022, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. [ 41 ] Support groups
Alnylam (ALNY) submits a marketing authorization application to the EMA for vutrisiran to treat adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
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 drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release.
The U.S. Food and Drug Administration (FDA) approved the drug for use in acute pain, but Vertex aims to eventually win approval in chronic pain, too. Clinical trials are ongoing, ...
Patisiran was granted orphan drug status, fast track designation, priority review and breakthrough therapy designation due to its novel mechanism and the rarity of the condition it treats. [14] [15] It was approved for medical use in the United States and in the European Union in August 2018.
A new opioid-free pain medication was approved by the U.S. Food and Drug Administration (FDA) on Thursday, marking a non-addictive alternative for patients. Journavx (suzetrigine), made by Vertex ...