FDA
Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.
ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.
In the next two weeks, the FDA will hand down its verdicts for three drug applications, including ones for multiple myeloma and hypoparathyroidism therapies.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
Citius Pharmaceuticals’ Lymphir is a reformulated version of denileukin diftitox—an FDA-approved cancer therapy—and the only treatment for cutaneous T cell lymphoma that targets the IL-2 receptor located on malignant T cells and Tregs.
Fabhalta is approved for the treatment of IgAN patients who are at risk of rapid disease progression, which is indicated by a urine protein-to-creatinine ratio of at least 1.5 g/g.
Crexont was previously rejected by the regulator in June 2023, citing insufficient safety data. However, Amneal Pharmaceuticals’ resubmission included findings from a healthy volunteer study.
Servier Pharmaceuticals’ vorasidenib on Tuesday secured the FDA’s green light for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene.
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.
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