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Romvimza: vimseltinib: 2/14/2025: To treat symptomatic tenosynovial giant cell tumor for which surgical. supplemental New Drug Application (sNDA) Catalyst Date: March 23, 2025: Catalyst: PDUFA Date: Announcement: Read More: Website: Click Here: Mar 26
FDA Drug Approval Process Timeline Romvimza: vimseltinib: 2/14/2025: To treat symptomatic tenosynovial giant cell tumor for which surgical. supplemental New Drug Application (sNDA) Catalyst Date: March 23, 2025: Catalyst: PDUFA Date: Announcement: Read More: Website: Click Here: Mar 26 Fast forward to January 2025, and the FDA approved a once-monthly maintenance dosage of Leqembi
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FDA PDUFA Calendar, PDUFA Dates, FDA Approval Dates BiopharmIQ . In June 2023, Leqembi (lecanemab) became the first fully FDA-approved medication of its kind of Alzheimer's disease It's thought to work by targeting beta-amyloid plaques to slow the progression of the disease
Drug Hunter Articles Archives . Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 5 See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.