The U.S. Food and Drug Administration (FDA) approved Anifrolumab for the treatment of moderate to severe systemic lupus erythematosus (SLE) in adults on July 30, 2021.
This submission seeks regulatory approval through the Therapeutic Goods Administration (TGA)’s Clinical Trial Notification scheme to initiate a first-in-human Phase 1 clinical trial for SAT-3247.
Aducanumab, sold under the brand name Aduhelm, is an intravenous medication used to treat Alzheimer's disease. Aducanumab was approved by the U.S. Food and Drug Administration (FDA) on June 7, 2021.
Rgenta Therapeutics secures FDA nod for IND application of RGT-61159, an oral RNA modulator intended to stop MYB production, targeting Adenoid Cystic Carcinoma (ACC) and Colorectal Cancer (CRC).
Ryplazim was approved by the U.S. Food and Drug Administration (FDA) on June 4, 2021. This approval marked a significant milestone as Ryplazim is the first therapy approved for treating plasminogen deficiency type 1.