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Axsome Therapeutics’ proprietary combination of dextromethorphan and bupropion — already approved for major depressive disorder as AXS-05 — also reduced the risk of agitation related to Alzheimer’s disease (AD), the company reported. Read More
Lysogene’s investigational gene therapy LYS-SAF302 preserved cognitive function and brain volume in a small set of infants with a devastating type of childhood dementia, mucopolysaccharidosis Type IIIA (MPS IIIA). Read More
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