Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson’s disease spectrum Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel […]
Tag: FDA Approval
The FDA Granted Orphan Drug Designation to Biostar Pharma’s Utidelone for the Treatment of Pancreatic Cancer
SAN FRANCISCO, Sept. 25, 2025 /PRNewswire/ — Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. (“Biostar,” stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the […]
Oobli Receives Third “No Questions” Letter from the FDA for Use of Novel Sweet Protein as a Sweetening Ingredient
“No questions” letter from U.S. Food and Drug Administration signals support for the safety of the oubli fruit sweet protein for use in food and beverages DAVIS, Calif., Sept. 24, 2025 /PRNewswire/ — Oobli, the first […]
Stealth BioTherapeutics Announces FDA Accelerated Approval of FORZINITY™ (elamipretide HCl), the First Therapy for Progressive and Life-limiting Ultra-rare Genetic Disease Barth Syndrome
NEEDHAM, Mass., Sept. 19, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that […]
TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen
TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn’s disease TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at […]
