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Pegcetacoplan is the first treatment for paroxysmal nocturnal hemoglobinuria that binds to and inhibits complement protein C3. [9] Pegcetacoplan was approved for medical use in the United States in May 2021. [9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [16]
The FDA accepts Apellis' (APLS) major amendment to the NDA for pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration. A decision is now due on Feb 26, 2023. Stock up.
WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE ® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by ...
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
ATC code L04 Immunosuppressants is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products.
Iptacopan was approved by the US Food and Drug Administration (FDA) for the treatment of adults with paroxysmal nocturnal hemoglobinuria in December 2023. [6] [7] The FDA considers it to be a first-in-class medication. [8]
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 ...
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