Anbogen Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, ...
AQNEURSA® could offer a new frontline treatment for NPC patients in Europe CHMP recommendation based on Phase III pivotal trial data and extensi...
Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first tre...
Engagement with FDA on GH001 IND complete response ongoing The fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months...
Sanofi announces the completion of its acquisition of Blueprint Medicines Corporation (Blueprint), adding to its portfolio a commercialized medicine, a p...
The U.S. Food and Drug Administration announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular ...
New Drug Application supported by results from the Phase 2b SunRISe-1 study Johnson & Johnson announced that the U.S. Food and Drug Administration (...
AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases, ann...
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. announced that the U.S. Food and Drug Administrat...
Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics L...
Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune d...
Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma"), a clinical-stage biopharmaceutical company dedicated to innovative drug development for liver and...
SimBioSys®, a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment, today announced its third FDA 510(k) c...
Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, announces that the U.S. Food and Drug A...
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