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Sellas Life Sciences is amending the statistical analysis in an ongoing phase 3 trial for acute myeloid leukemia after a preliminary data review found that patients enrolled were living twice as long as originally projected. Read More
Addressing sponsors’ desires to evaluate multiple versions of cell and gene therapy candidates in a single early phase trial, the FDA has issued guidance that encourages separate Investigational Drug Applications (INDs) but under an umbrella trial design. Read More
Neurotech Pharmaceuticals has announced positive phase 3 topline results from two trials evaluating its NT-501 eye treatment for patients with macular telangiectasia type 2 (MacTel). Read More
GSK’s Blenrep (belantamab mafodotin), an antibody-drug conjugate that won accelerated approval in 2020, has failed its required confirmatory study as a treatment for relapsed or refractory multiple myeloma (RRMM), missing its primary endpoint. Read More
New 24-month data will delay the FDA’s decision for Apellis Pharmaceuticals’ investigational therapy for the rare eye disease geographic atrophy (GA) until February, but — according to the company — will strengthen the case for approval. Read More
Pfizer announced Tuesday that its bivalent respiratory syncytial virus (RSV) vaccine candidate met one of two primary endpoints when administered to pregnant participants to help protect their infants from RSV disease after birth. Read More