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The decision was supported by efficacy data from 36 patients from the ongoing phase 1/2 HGB-206 trial (NCT02140554) and 2 patients in the phase 3 HGB-210 trial (NCT04293185). It was the second approval from FDA for a gene therapy for sickle cell disease.
FDA has posted an Addendum to Briefing Document on its website that was circulated to members of the AdCom ... | May 9, 2023
A rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational small molecule, cell and... | April 3, 2023
– Mr. Johnson brings broad commercial expertise with over 30 years of leadership spanning dermatology marketing, sales, sales management, digital marketing...
Soligenix Receives Conditional FDA Acceptance of Proposed Brand Name HyBryte™ for SGX301 in CTCL News provided by Share this article Share this article PRINCETON, N.J., April 7, 2021 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin), the Company's novel fi...