DURHAM, N.C. — Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted the application Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action...
treatment News
DURHAM, N.C. — Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved LISRAYA™ (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM). LISRAYA is a pill taken once daily. DM is a rare systemic autoimmune disease characterized by progressive muscle weakness and extensive,...
DURHAM, N.C. — Priovant today announced a new Phase 2b/3 clinical program for brepocitinib in lichen planopilaris (LPP), a highly morbid inflammatory scalp disorder affecting approximately 100,000 adults in the United States. LPP inflammation targets the stem cell-rich bulge region of the hair follicle (the permanent portion responsible for hair growth),...
Berlin, Germany – ProBioGen and Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases, today announced the successful completion of a sprint project to deliver clinical material. The partnership focused on an integrated and accelerated chemistry, manufacturing,...
VERO BEACH, Fla. — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, today announced that its abstract, “Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)”, has been accepted for presentation at...
NEW YORK, NY — ProJenX, a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced that it has received authorization in the European Union (EU) for study PRO-101, a hybrid Phase 1 clinical trial...
SAN FRANCISCO, Calif. — ProLynx Inc. announced today that the first patient was treated with PLX038 (PEGylated SN-38) in a Phase I/II clinical trial for primary CNS tumors driven by MYC or MYCN amplifications. National Institutes of Health’s NCI investigators Dr. Marta Penas-Prado and Dr. Mark Gilbert are conducting the...
MADISON, Wis. — A new study published in Nature Communications reveals technological advances that accelerate breakthroughs in precision medicine. Conducted as a collaboration between Promega, the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook, and the Centre for Medicines Discovery at the University...
PHILADELPHIA, PA — Virion Therapeutics, LLC, a clinical-stage biotechnology company, developing novel T cell-based immunotherapies, today announced promising safety results from the first-ever human data from its novel, first-in-class, checkpoint modifier immunotherapy, VRON-0200, for HBV functional cure, presented by Professor Grace Wong, M.D., from the Chinese University of Hong Kong,...
Tokyo, Japan – Scientific advances in the last century have changed our world significantly. For example, the world of genetics has opened doors to a myriad of possibilities: augmented human capabilities, cures for diseases, and even changes to the course of evolution. In a study published last month in Communications...