BioSpace News Archive

Genetown

Apellis Provides Update on Review of Rare Safety Events with SYFOVRE® (pegcetacoplan injection) for Geographic Atrophy

Apellis Pharmaceuticals, Inc. provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with SYFOVRE® for geographic atrophy secondary to age-related macular degeneration.

July 29, 2023
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10 min read
Policy

Citius Pharmaceuticals, Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the Company’s Biologics License Application seeking approval for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy.

July 29, 2023
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6 min read
Drug Development

4DMT Presents Additional Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ASRS 2023

4D Molecular Therapeutics announced additional positive interim clinical data from the Phase 1 Dose Exploration stage of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration.

July 29, 2023
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9 min read
Pharm Country

Aflibercept 8 mg Two-Year Results from Pivotal PHOTON Trial in Diabetic Macular Edema Presented at ASRS

Regeneron Pharmaceuticals, Inc. announced the first presentation of positive two-year results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA® Injection, in patients with diabetic macular edema.

July 29, 2023
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15 min read