FDA News

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the European Commission has granted conditional marketing authorization for ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. ANKTIVA in combination with BCG is the firs...

WARSAW, Poland--(BUSINESS WIRE)--Rezon Bio announces that its Warsaw-Duchnice facility has received approval from the U.S. Food and Drug Administration (FDA) for the commercial manufacturing of a biosimilar. This milestone represents an important step in the continued development of Rezon Bio’s global manufacturing network and reflects the company’s focus on building robust, compliant, and reliable capabilities to support biologic therapies for patients worldwide. The FDA approval of the Warsaw...

PHILADELPHIA--(BUSINESS WIRE)--GSK’s AREXVY associated with reductions in certain RSV-related risks, real world study shows...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology to advance musculoskeletal health, today announced that management will participate in the following investor conferences: TD Cowen 46th Annual Health Care Conference: Schol...

ATLANTA--(BUSINESS WIRE)--Axion BioSystems today announced that the FDA's Center for Drug Evaluation and Research (CDER) has accepted the company’s letter of intent (LOI) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Program for its Human iPSC-Cardiomyocyte MEA Assay for Prediction of Clinical Cardiovascular Repolarization Risk. The submission represents the first stem cell-derived, functional cardiac safety assay accepted into the ISTAND program. The ISTAND progr...

WALTHAM, Mass.--(BUSINESS WIRE)--Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the European Medicines Agency (EMA) has granted Orphan Drug designation to Affinia for AFTX-201. AFTX-201 is a potential first-in-class and best-in-class investigational genetic medicine for the treatment of BAG3-associated di...

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that new preclinical study data supporting the potential safety and long-term efficacy of PBGENE-DMD has been selected as a poster presentation at the upcoming 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference taking plac...

NEW YORK & MELBOURNE, Australia--(BUSINESS WIRE)--Radformation, a leading provider of intelligent automation solutions for radiation oncology, and Icon Group (Icon), a leading global integrated cancer care provider, today announced the initial deployment of ChartCheck Adaptive, Radformation’s Offline Adaptive Assessment solution, across 15 cancer centres in Australia. The rollout reflects the growing clinical value of automated adaptive assessment workflows within routine radiotherapy practice....

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the successful completion of Type B meetings with the U.S. Food and Drug Administration (FDA or the Agency) regarding its planned upcoming biologics license application (BLA) submission for tralesinidase alfa enzyme replacement therapy...

LOS ANGELES--(BUSINESS WIRE)--Lindora appoints JJ Virgin as Chief Metabolic Health Officer to lead muscle-first programming and advance outcomes-driven metabolic care nationwide....