Identifier
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
UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data
UniQure, Huntington’s disease, gene therapy, AMT-130, FDA, RMAT designation, Phase I/II clinical trials, neurodegenerative disorder, neurofilament light (NfL), disease progression, composite Unified Huntington’s Disease Rating Scale (cUHDRS).
Eli Lilly Anticipates Zepbound Label Expansion Following Positive Phase III Sleep Apnea Study Results
Eli Lilly, Zepbound (tirzepatide), Phase III Sleep Apnea Study, SURMOUNT-OSA, Obstructive Sleep Apnea (OSA), Label Expansion, Fast Track Designation, Symptom Improvement