Functional Concept – Page 36

FDA Places Clinical Hold on PepGen’s Duchenne Muscular Dystrophy Trial

7 months ago talkbio0Tagged Duchenne, Muscular Dystrophy, PepGen, Study on Hold, United States Food and Drug Administration

FDA, Clinical Hold, PepGen, Duchenne Muscular Dystrophy, PGN-EDO51, CONNECT2-EDO51

PureTech’s Deupirfenidone (LYT-100) Demonstrates Superior Efficacy in Slowing Lung Function Decline in Idiopathic Pulmonary Fibrosis (IPF) Phase 2b Trial

7 months ago talkbio0Tagged decline, Fibrosis, High, Idiopathic Pulmonary Fibrosis, Lung, LYT 100, Phase 2b Trial, pirfenidone, PureTech Health, Respiratory physiology

PureTech Health, Deupirfenidone (LYT-100), Idiopathic Pulmonary Fibrosis (IPF), Lung Function Decline, Phase 2b Trial, ELEVATE IPF Trial, Pulmonary Fibrosis Treatment

Reviva’s Brilaroxazine Demonstrates Efficacy and Safety in Long-Term Schizophrenia Treatment

7 months ago talkbio0Tagged Ability to perform cognitive activity, Antipsychotic Agents, Brilaroxazine, Effectiveness, Long-term, Negative, Safety, Schizophrenia, Symptoms aspect

Brilaroxazine, Schizophrenia treatment, Antipsychotic medication, Efficacy and safety, Long-term treatment, Negative symptoms, Cognitive functioning

FDA Approves UNLOXCYT for Advanced Cutaneous Squamous Cell Carcinoma, Marking a New Era in Skin Cancer Treatment

7 months ago talkbio0Tagged Approved, checkpoint inhibitor, cosibelimab-ipdl, Immunotherapy, Malignant neoplasm of skin, Squamous cell carcinoma, Squamous cell carcinoma of skin, United States Food and Drug Administration, UNLOXCYT

UNLOXCYT, cosibelimab-ipdl, FDA approval, advanced cutaneous squamous cell carcinoma (cSCC), checkpoint inhibitor, immunotherapy, skin cancer treatment.

Advancements in ctDNA Testing for Early Detection of Breast Cancer Recurrence

7 months ago talkbio0Tagged Breast Cancer Recurrence, Circulating, ctDNA, Detection, Liquid Biopsy, Molecular residual disease, Whole Genome Sequencing

ctDNA (circulating tumor DNA), Breast Cancer Recurrence, Early Detection, Liquid Biopsy, Whole Genome Sequencing, Molecular Residual Disease

Biotech Industry Prepares for Trump 2.0: Regulatory Changes and M&A Activity Expected

7 months ago talkbio0Tagged biotech industry, Changing, Drug Industry, Health Policy, M&A activity, regulatory environment, Transplant Registry Unified Management Program, United States Food and Drug Administration

Biotech industry, Trump 2.0, FDA changes, M&A activity, regulatory environment, pharmaceutical industry, healthcare policy

Eli Lilly and Ro Partner to Expand Access to Affordable Zepbound Single-Dose Vials for Obesity Treatment

7 months ago talkbio0Tagged Affordable medication, CALR gene, Eli, Eli Lilly, Obesity, Pharmaceutical Services, Self-pay, single-dose, Telemedicine, Zepbound

Eli Lilly, Ro, Zepbound, Single-dose vials, Obesity treatment, Telehealth, Affordable medication, Self-pay pharmacy

Acelyrin Reassesses Flagship Immunology Asset Izokibep Following Multiple Clinical Trial Setbacks

7 months ago talkbio0Tagged Acelyrin, Arthritis, Psoriatic, biotech, Clinical Trials, Failure (biologic function), Hidradenitis, Immunology, IPO, Izokibep, suppurativa

Acelyrin, Izokibep, Clinical Trial Failure, Immunology, Hidradenitis Suppurativa, Psoriatic Arthritis, Biotech IPO

uniQure Secures FDA Agreement on Accelerated Approval Pathway for Huntington’s Disease Gene Therapy AMT-130

7 months ago talkbio0Tagged Accelerated, AMT-130, Approved, cUHDRS, gene therapy, Huntington 's disease, NEFL gene, NfL, Regenerative Medicine, RMAT, UniQure, United States Food and Drug Administration

uniQure, FDA, Accelerated Approval, Huntington’s Disease, Gene Therapy, AMT-130, cUHDRS, Neurofilament Light Chain (NfL), Regenerative Medicine Advanced Therapy (RMAT)

Cardiff Oncology’s Onvansertib Shows Promising Results in First-Line RAS-Mutated Metastatic Colorectal Cancer Trial

7 months ago talkbio0Tagged Cardiff Oncology, first-line, onvansertib, ORR, Phase 2, RAS, RAS-mutated

Cardiff Oncology, Onvansertib, RAS-mutated metastatic colorectal cancer, Phase 2 CRDF-004 trial, objective response rate (ORR), first-line treatment.