FDA Approves Kevzara® (Sarilumab) for Treating Polymyalgia Rheumatica (PMR)
Regeneron Pharmaceuticals, Inc. and Sanofi have received FDA approval for Kevzara® (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients who have not responded well to corticosteroids or ...
SpringWorks Therapeutics’ Nirogacestat Granted Priority Review by FDA for Desmoid Tumor Treatment
SpringWorks Therapeutics, a clinical-stage biopharmaceutical company, has received acceptance from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for nirogacestat, an i ...
Genetic mutations associated with Alzheimer’s disease risk
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FDA Approves Apellis’ SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy (GA)
Apellis Pharmaceuticals, Inc. announced today that SYFOVRE™ (pegcetacoplan injection) has been approved by the United States Food and Drug Administration (FDA) for the treatment of geographic atrophy ...
PharmaDrug Inc. Announces Plans for First-In-Human Clinical Study with PD-001 in Esophageal Cancer
PharmaDrug Inc. plans to conduct a first-in-human study of its lead candidate, PD-001, an enteric-coated cepharanthine-2HCL, in Australia in H2 2023. PD-001 has the potential as a breakthrough therapy ...
Jubilant Therapeutics’ JBI-778 Granted Orphan Drug Designation by US FDA for Glioblastoma Multiforme Treatment
Jubilant Therapeutics, a clinical-stage biopharmaceutical company, has announced that JBI-778, an oral PRMT5 inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration ...
IASO Bio’s CT103A Receives RMAT & Fast Track Designation from FDA for Treating Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics, a clinical-stage biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMA ...
Everest Medicines Announces South Korea Grants Fast-Track Review Designation to Nefecon for Primary IgA Nephropathy Treatment
Everest Medicines, a biopharmaceutical company developing and commercializing innovative pharmaceuticals and vaccines in Asia, has received Global Innovative product on Fast Track (GIFT) designation f ...
Kura Oncology Announces First Patients Dosed in Phase 2 Trial of Ziftomenib in NPM1-Mutant Acute Myeloid Leukemia
Kura Oncology Inc., a clinical-stage biopharmaceutical company dedicated to realizing the promise of precision medicines for cancer treatment, announced today that the first patients in its KOMET-001 ...
Awakn Life Sciences Corp. Receives U.K. MHRA’s Innovative Licensing for its Breakthrough Therapy for Severe Alcohol Use Disorder
Awakn Life Sciences Corp., a biotechnology company specializing in developing addiction therapies with a primary focus on Alcohol Use Disorder (AUD), announces that U.K. MHRA has granted Innovation Pa ...