Identifier
Neurona nabs $102M to launch pivotal trial of epilepsy cell therapy
MTLE, Epilepsy, Cell Therapy, RMAT, Identifier, drug-resistant
Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs
Kura Oncology’s Ziftomenib Achieves Phase 2 Success in AML, Paving Way for Dual-Track Phase 3 Program
Ziftomenib, Acute Myeloid Leukemia (AML), NPM1 mutation, KMT2A rearrangement, Phase 3 trials, KOMET-001, KOMET-017, Menin inhibitor, Breakthrough Therapy Designation
Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug
FDA, Vanda Pharmaceuticals, Fast Track Designation, Gastroparesis, Drug Approval Process
Corcept’s ALS Drug Trial Misses Primary Endpoint, Yet Shows Promising Survival Benefit
Corcept Therapeutics, Dazucorilant, ALS (Amyotrophic Lateral Sclerosis), Phase 2 trial, Survival benefit, Fast Track Designation, Cortisol modulator
FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC
Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review
Cybin’s Psychedelic Breakthroughs: Advancing Mental Health Treatments
Cybin, psychedelic therapeutics, mental health treatments, deuterated psilocybin, deuterated DMT, clinical trials, FDA Breakthrough Therapy Designation.
Roche Advances Alzheimer’s Disease Diagnosis with Breakthrough Blood Test
Alzheimer’s disease, blood test, Roche, Eli Lilly, FDA breakthrough device designation, pTau217, amyloid pathology, early diagnosis.
ProKidney Streamlines Phase 3 Program to Expedite U.S. Approval of Rilparencel for Chronic Kidney Disease
ProKidney, rilparencel, chronic kidney disease, CKD, cell therapy, RMAT designation, FDA approval, Phase 3 trial
uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease
uniQure, Huntington’s disease, AMT-130, gene therapy, Phase I/II trials, disease progression, neurofilament light protein (NfL), Unified Huntington’s Disease Rating Scale (cUHDRS), Regenerative Medicine Advanced Therapy (RMAT) designation