BioSpace News Archive

ExCellThera Inc. (ExCellThera), an advanced clinical-stage biotechnology company delivering molecules and bioengineering solutions to expand and engineer various cell lines for use in next generation cell and gene therapies, announced today that it has submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for UM171.

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Kazia’s paxalisib for the treatment of atypical rhabdoid / teratoid tumors.

Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn’s disease, ADVANCE, MOTIVATE and FORTIFY 1-4.

Study to support U.S. FDA approval of the novel CLAAS® implant for left atrial appendage occlusion (LAAO) and stroke prevention.

RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it will report its first quarter 2022 financial results and operational highlights on Thursday, June 23, 2022.

General Counsel and Chief Technology Officer to Step Down in July 2022.

Last night bit.bio won the Emerging Star prize at the European Mediscience Awards in a ceremony at the Hotel InterContinental in London.

Carisma Therapeutics , a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, will be hosting a webcast on June 24th at 1:00pm ET to present and discuss the latest data from its landmark, first-in-human chimeric antigen receptor macrophages (CAR-M) study of leading asset CT-0508.