Capricor Therapeutics Begins BLA Submission for Deramiocel to Treat DMD Cardiomyopathy
Capricor Therapeutics, a biotechnology company dedicated to developing transformative cell and exosome-based therapeutics for rare diseases, has announced the initiation of its rolling submission proc ...
Dizal’s Sunvozertinib Receives Breakthrough Therapy Designation for First-Line NSCLC Treatment
Dizal, a biopharmaceutical company dedicated to the development of novel treatments for cancer and immunological diseases, has announced that the Center for Drug Evaluation (CDE) of China's National M ...
Clearmind Medicine Receives IRB Approval for Phase I/IIa Clinical Trial of CMND-100 Targeting Alcohol Use Disorder
Clearmind Medicine Inc., a clinical-stage biotech company dedicated to the discovery and development of innovative psychedelic-derived therapeutics for major under-treated health issues, has received ...
FDA Grants Breakthrough Therapy Designation to Mirum’s Volixibat for Cholestatic Pruritus in PBC
Mirum Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough therapy designation to their drug, volixibat, as a potential treatment for cholestat ...
2024 ISPOR Annual Meeting Highlights – Anticipated impact of Inflation Reduction Act (Part 2)
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2024 ISPOR Annual Meeting Highlights – Anticipated impact of Inflation Reduction Act (Part 1)
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Primary Brain Tumor Overview and Insights
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FDA Grants Fast Track Designation to MorphoSys AG’s Promising Endometrial Cancer Treatment
MorphoSys AG today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tulmimetostat, an innovative dual inhibitor targeting EZH2 and EZH1. This breakthro ...
CyGenica Receives Orphan Drug Designation for Glioblastoma Multiforme (GBM) Treatment
CyGenica Limited, a dynamic biotech startup, has achieved a significant milestone in the fight against Glioblastoma Multiforme (GBM), an aggressive form of brain cancer. Dr. Nusrat J M Sanghamitra, Co ...
Healx Secures FDA Orphan Drug Designation for AI-Discovered NF1 Treatment – HLX-1502 Unveiled!
Healx, a cutting-edge techbio company driven by AI innovation and patient-centricity, has achieved Orphan Drug Designation from the US Food and Drug Administration (FDA) for its groundbreaking AI-driv ...